Philips Consumer Lifestyle B.V.

127 recall(s) on record — most severe on record: Class I.

Devices registered here (1)

• Shield, Nipple
  Product code HFS · Class I · General Hospital · 21 CFR 880.5630

Recalls & enforcement

• Class ITerminated2019-09-19
  An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
• Class IITerminated2019-06-24
  In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
• Class IITerminated2019-06-10
  An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
• Class IITerminated2019-06-03
  The Vereos PET/CT may have misaligned front and rear covers, which may result in gaps between cover parts and/or protrusion of the cover into the bore diameter.
• Class IITerminated2018-12-19
  A software update is being issued to correct multiple issues identified in the previous software version.
• Class IITerminated2018-10-18
  There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
• Class IITerminated2018-09-04
  Software Correction: Software errors that may result in incorrect 4D CT images, PET images with SUV quantification error, or disruption of interventional CT procedures; and Software errors that may result in partial set of images, inability to generate CT or PET images, incorrect
• Class IITerminated2018-07-03
  Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator being past its lifetime expected usage.
• Class IITerminated2018-05-21
  The block used to connect the patient pallet to the couch may be assembled incorrectly. A screw may be misaligned in the patient pallet.
• Class IITerminated2018-03-30
  The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require medical intervention to preclude permanent impairment in certain scenarios.
• Class IITerminated2018-03-28
  A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
• Class IITerminated2018-02-21
  Surview scan with tube current lower than 30 mA is unable to be initialized.
• Class IITerminated2018-02-15
  Following a period of inactivity, the mass storage device may cause the acquisition console to become unresponsive. This may prevent an acquisition from proceeding.
• Class IITerminated2018-02-08
  Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
• Class IITerminated2018-01-11
  23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Software errors that may result in CT spectral images misrepresentation or incorrect treatment; " Software errors that may result in partial set of images or inabi
• Class IITerminated2018-01-03
  Software issues including: Software errors that may result in Extended Field of View check message not displayed when Field of View is set >600 mm for a paused scan; Request for change to automatically turn on the center x/y 0 setting and the disable result rotation setting
• Class IITerminated2017-12-15
  During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may
• Class IITerminated2017-12-11
  A software issue causes PET reconstructions to fail intermittently. It was determined that reconstructions fail due to a negative table position (-1 value is inserted) in the raw data list file, rather than the actual table position. This error has been found to occur in two sce
• Class IITerminated2017-11-10
  Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a
• Class IITerminated2017-11-08
  There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.
• Class IITerminated2017-11-01
  One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware.
• Class IITerminated2017-10-06
  Numerous issues related to software Brilliance iCT 4.1.6 software version.
• Class IITerminated2017-07-11
  Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions.
• Class IITerminated2017-06-07
  It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patien
• Class IITerminated2017-02-24
  The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.
• Class IITerminated2017-02-23
  When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific ph
• Class IITerminated2017-01-31
  Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan
• Class IITerminated2016-12-23
  During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued.
• Class IITerminated2016-12-23
  The intended use listed in the English and localized language IFUs for BrightView XCT systems did not match the intended use documented in the 510K submission.
• Class IITerminated2016-12-16
  Multiple issues have caused the device to result in CT rescans or incorrect scan location or misrepresentation of image results.
• Class IITerminated2016-11-25
  Failure to correctly document the installation of four M12 Bolts into the system rotor.
• Class IITerminated2016-11-18
  There's a potential for liquid penetration into the back side of the front control panel of the X-ray diagnostic table, which can cause a short circuit of the terminals of the tilt operation and cause an unintentional tilt of the table.
• Class IITerminated2016-11-14
  A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images
• Class IITerminated2016-11-12
  Software error due to the filament on timer
• Class IIITerminated2016-10-13
  The product label does not include the correct current rating.
• Class IITerminated2016-08-24
  The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of t
• Class IITerminated2016-07-20
  After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at iso-center (0,0). If the region of interest
• Class IITerminated2016-06-21
  Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack causing injury to patients, operators, by-standers and service personnel.
• Class IITerminated2016-06-14
  Socket Head Cap Screws (SHCS) used in the Z-Axis Adjustment Plate were found to be made of stainless steel rather than the specified alloy steel.
• Class IITerminated2016-05-25
  The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was caused by a software defect in the workflow setup script.
• Class IITerminated2016-04-29
  Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance of the equipment.
• Class IITerminated2016-04-20
  The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: 1. During the filming operation on MX16-slice console software, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to copy the c
• Class IITerminated2016-04-08
  The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
• Class IITerminated2016-04-01
  Philips Healthcare received reports from the field that certain Ingenuity Core128 systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images. A patient rescan may be required if the images cannot be used for in
• Class IITerminated2016-03-24
  Software defect causing intermittently slow response of Host.
• Class IITerminated2016-03-04
  The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gamma cameras allow for other relative detector angles. Data acquired at these other angles will not be
• Class IITerminated2016-02-05
  The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
• Class IITerminated2015-12-17
  The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet. If this occurs,
• Class IITerminated2015-10-29
  Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial pe
• Class IITerminated2015-09-14
  The firm discovered Ring/Dot artifact due to X-ray measurement error.
• Class IITerminated2015-07-23
  Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruction Server (PRS) database may lock up after an MR acquisition is completed and before a PET acquisition is begun, even though no actual database lockup issue has been reported in the
• Class IITerminated2015-07-01
  Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.
• Class IITerminated2015-04-13
  A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners.
• Class IITerminated2015-03-17
  A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity CT, which was shipped with this system.
• Class IITerminated2015-03-16
  The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
• Class IITerminated2015-03-13
  During clinical use of a Vertex Plus Gamma Camera, as the detector heads were in the relative 180 degree position, Detector #1 drifted down and made contact with the patients chin during a whole body study acquisition.
• Class IITerminated2015-03-11
  It was noticed that the spectroscopy voxel map did not align with the anatomical images of the phantom. This resulted in incorrect orientation of the Chemical Shift Imaging (CSI) data.
• Class IITerminated2015-03-11
  The firm was notified by a customer that the collimator exchange carriage and the collimator storage cabinet were misaligned.
• Class IITerminated2015-03-06
  The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.
• Class IITerminated2015-02-05
  5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation missing for some images when manual contrast was administered. Dot artifact present, intermittently, after startup. Heart Rate measured value incorrectly remains constant for some heart r
• Class IITerminated2015-02-05
  Philips discovered that a software defect exists in marketed product wherein the sign indication of the longitudinal position of some types of scan is inverted.
• Class IITerminated2014-12-08
  Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion.
• Class IITerminated2014-11-12
  Unintended detector and gantry movement due to software issues.
• Class IITerminated2014-11-09
  Software defect. In certain circumstances, the application may display incorrect measurements of cardiac and aortic anatomy used to select and size the Transcatheter heart valve (THV) to be implanted .
• Class IITerminated2014-11-04
  Software issues
• Class IIOngoing2014-10-09
  "The orientation of images is displayed incorrectly. When operator chooses gantry on the right side from operation console, and the patient position is HFDL, HFDR, FFDL or FFDR, the patient position picture and text is not consistent. "L" and &quo
• Class IITerminated2014-09-11
  Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order that it was taken by the user.
• Class IITerminated2014-07-27
  The following software issues have been identified in the affected products. Problem 1: When reopening a bookmark generated from processing a MUGA (Multi-Gated Acquisition) scan within the NM Cardiac Application, the ejection fraction (EF) displayed should be the same as the eje
• Class IITerminated2014-06-23
  Flat Panel Display (FPD) failed to remain securely locked in the deployed position.
• Class IITerminated2014-06-18
  When beginning a procedure to start the gantry and CT Host, a Close Estop message may appear to the operator, but disappears before action can be taken. If this occurs it results in an inability to close E-Stop and the system is not operational for clinical use. This problem occ
• Class IITerminated2014-04-01
  A customer reported that the table top had become free floating. A Field Service Engineer (FSE) confirmed that the service latch had become disengaged.
• Class IITerminated2014-03-27
  Block assembly-lock stop subframe of service latch was not manufactured to engineering specifications from the supplier, causing premature fracture of the threaded rod on the patient support service latch. As a result, the table top can become free floating due to the disengaged
• Class IITerminated2014-03-11
  During SPECT reconstructions using Attenuation Correction and Scatter Correction, no Scatter Correction is being applied in the AutoSPECT Pro application on IntelliSpace Portal. In addition, resolution recovery is not applied correctly in SPECT reconstructions using Astonish in
• Class IITerminated2014-03-10
  Slippage of the radius drive belt in the relative 180 degree orientation of the superior positioned detector head will allow the detector head to drift down and potentially come in direct contact with the patient.
• Class IITerminated2014-03-06
  A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions would intermittently not complete.
• Class IITerminated2014-02-11
  Philips Medical Systems have recently determined that a software nonconformance can cause incorrect beam geometry. This issue affects Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0 manufactured from 09/29/09 to 12/01/2013.
• Class IITerminated2013-12-19
  Three problems were reported to the firm: When positioning for a relative 180 degree non circular acquisition the second (bottom) detector was not positioned correctly causing an inappropriate rotation orbit calculation. When the acquisition was started and the detectors bega
• Class IITerminated2013-12-19
  During internal testing, the Brilliance CT Big Bore was found to be out of tolerance for radio frequency emissions. Specifically, at the 48MHZ frequency, the testing indicated the Brilliance CT Big Bore was 3.5dB uV/meter higher than the applicable IEC 60601-1-2 standard specific
• Class IITerminated2013-12-09
  Patient images exhibited ring artifacts.
• Class IITerminated2013-12-05
  The TF Big Bore patient table experienced mechanical binding during horizontal table motion resulting in an automatic Emergency Stop (E-stop). An E-Stop will interrupt a current scan, resulting in an incomplete study.
• Class IITerminated2013-12-04
  Machine Name in TumorLOC Basic Mode is obscured. When TumorLOC is in Basic Mode and Set Vertical Laser equals Yes, the Machine Name label and field are covered by the controls above it. The Machine Name cannot be viewed or changed.
• Class IITerminated2013-12-04
  The recalling firm determined that visual inspections of the fork joints behind the detector that are conducted during six month preventive maintenance (PM) may not detect small cracks or deficiencies in the fork weldment.
• Class IITerminated2013-12-04
  The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is complete and will not allow the PET acquisition to begin, resulting in an unexpected incomplete study.
• Class IITerminated2013-10-11
  If the couch, with the footrest extension attached, is positioned where the table travel is within the bore of the gantry, and the user begins to lower the couch, the footrest extension can contact the gantry cover or come in contact with the user due to the length of the accesso
• Class IITerminated2013-09-03
  Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain securely latched in the stowed position.
• Class IITerminated2013-08-30
  There are artifacts appearing on the Tracker images during threshold-triggered bolus scans with protocols using a Rotation Time of 0.4 seconds.
• Class IITerminated2013-08-16
  Issues with the Ingenuity TF PET/CT Software Version 4.0 could pose a risk for patients in the event that a patient rescan were to require reinjection of PET radiopharmaceutical.
• Class IITerminated2013-08-07
  There is a potential for water to collect in the vent pipe elbow in the magnet venting system. Water may freeze, blocking the venting system.
• Class IITerminated2013-07-22
  A pinch point at the end of the table top can cause injury.
• Class IITerminated2013-07-16
  An artifact that resembles thrombus may appear on the image.
• Class IITerminated2013-07-05
  The patient support may move in an unintended manner if the footswitch cover impinges on the footswitch.
• Class IITerminated2013-04-25
  Philips has received one report from the field that there was an unexpected motion of the detector due to a failure of the mechanical assembly.
• Class IITerminated2013-04-15
  Philips Healthcare received reports from the field that certain Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 systems running software versions 2.6.1 or 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images, which may impair the
• Class IITerminated2013-03-21
  If the operator selects a patient name from the worklist using the mouse and then selects a different patient name using the keyboard (arrow keys then press enter) the patient name that populates the exam information page is the patient name selected with the mouse. Also, it
• Class IITerminated2013-03-12
  Philips Healthcare received a report from the field stating when they viewed the CTDIVol information from the PACS system, the calculations were too high. Instead of storing the CTDIVol value for each slice in the DICOM tag, the system took the sum of all CTDIVol values from all
• Class IITerminated2013-02-15
  This field change order is being released to update software and customer release notes to the affected installed base.
• Class IITerminated2013-02-12
  Philips was notified of a problem using the IntelliSpace Portal with software version 4.0.2 with the URL PACS integration. Philips was informed that when loading a study to an analysis application while using URL PACS integration configuration, after another study was opened by a
• Class IITerminated2013-01-21
  The system may not default to the same gating trigger with which the data were acquired. This could cause a risk for patients.
• Class IITerminated2012-12-20
  Philips Healthcare received reports from the field stating the patient table on a system had an unexpected downward movement while a patient was on the table. Philips has determined the cause was a malfunction of the vertical brake.
• Class IITerminated2012-12-20
  Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605.0 that if they were to re-occur, could cause a risk for patients, users or service personnel, including inaccurate standard uptake values (SUV). Philips Medical Systems (Cleveland),
• Class IITerminated2012-12-19
  The four screws that secure the patient table top to the carrier became loose, which caused the table top to detach.
• Class IITerminated2012-12-03
  Software anomalies. Philips Medical Systems recalled their Brilliance 64 running software v4.0.0xx516 and their Ingenuity CT running software v4.0.0xx518 due to software issues detected in these CT scanning systems. If these issues were to re-occur they could pose the risk of i
• Class IITerminated2012-10-24
  Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated d
• Class IITerminated2012-10-05
  Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and subsequent distribution.
• Class IITerminated2012-09-28
  Incorrect values may be displayed. Philips is issuing a software update (version 4.5.5) to the Extended Brilliance Workspace (EBW) systems currently running software version(s) 4.0.2, V4.5.2 or V4.5.3, addressing a number of non-conformances.
• Class IITerminated2012-09-28
  Philips is issued a Field Change Order to update Extended Brilliance Workspace (EBW) systems to software version 4.5.5. The update will provide a number of improvements to address nonhazardous reliability issues which will improve the overall quality and functionality of the EBW
• Class IITerminated2012-09-18
  The low contrast pins in the Image Quality (IQ) phantom deteriorates over time. This prevents the customers from doing the Daily Image Quality Checks as defined in the current Instructions for Use (IfU).
• Class IITerminated2012-09-11
  Philips was notified that when performing post processing with the Brilliance Workspace Portal platform with software versions 2.6.1.4, the coronary arteries in the rendered image are segmented automatically. However, the center line is not extracted or highlighted upon hovering
• Class IITerminated2012-08-31
  Philips Healthcare received a complaint stating the system opens e-stop while sitting idle causing all movements and scan to stop. The problem has only occurred one time when the scan was out of Ready for Scan or scanning mode.
• Class IIITerminated2012-08-28
  Philips was notified that the system logout in software version 2.3.6 is now longer and may sometimes fail to logout, requiring a forced system restart or hard shutdown with the power button.
• Class IITerminated2012-08-24
  On August 24, 2012 the firm recalled the MX 16-slice after discovering that a bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.
• Class IITerminated2012-08-21
  A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.
• Class IITerminated2012-08-08
  Philips became aware of an issue relating to a UPS battery cabinet that appeared to have burned a hole through the casing on one of the batteries. Supplier of the UPS, Chloride/Emerson, determined the batteries, housed within the UPS battery cabinet, entered thermal runaway causi
• Class IITerminated2012-08-03
  The patient support may move in an unintended manner if the foot switch cover becomes damaged and impinges on the foot switch.
• Class IITerminated2012-07-18
  1. The current system design of software version 4.0.0xx379 does not prevent the system from scanning if the dose level exceeds a set upper dose limit for CT Brain Perfusion scanning, which previous versions did. However, the current version does have the Dose Check (NEMA XR-25)
• Class IITerminated2012-07-02
  Philips Healthcare was notified that several of the sixteen bolts securing the brackets which support the carbon table top on various models of their Brilliant CT scanner have been found to be defective and the bolt heads may break off.
• Class IITerminated2012-05-23
  The Intellispace Portal software and Extended Brillance Workspace software may have significantly different results in the colors and size of the affected area when the customer uses the "Time Sensitive" and "Time Insensitive" methods.
• Class IITerminated2012-05-23
  Philips is issuing a software update to the Intellispace Portal systems to address a number of non-conformances. The most frequent and severe non-conformance identified involves the portal setting of "PAC Integration". This setting has a feature that allows the user to
• Class IITerminated2012-05-22
  In the Multi-Modality Tumor Tracking application, when changing the contours of the lesion using the editing mode "edit contour" tool, the measurements are not recalculated causing discrepancies with the lesion measurements.
• Class IITerminated2012-05-07
  Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems currently running software version 3.2.0, 3.2.1 or 3.2.3, addressing a number of non-conformances. A review was conducted of all nonconformances that are fixed by the software upgrade.
• Class IITerminated2011-09-01
  During a Field Test (a customer external evaluation period), the customer detected a problem in the CIRS 4.0 Beta 2 software. When using the CIRS 4.0 Beta 2 software, during the recon during ready stage of reconstruction, images may be overlapped with, or superimposed on other i
• Class IITerminated2011-03-07
  The DoseRight feature suggest a mAs based on the measured patient size, a reference size and a reference mAs. When scanning large children, the suggested mAs may be higher than clinicians would expect.
• Class IITerminated2011-03-03
  Multiple software defects which could impact the performance or reliability of the system. These impacts include, but are not limited to: error messages which prevent operation, incorrect scan region, couch movement failure, inaccurate CTDI reporting, image artifacts, lost image
• Class IITerminated2008-05-01
  The reason for this inspection is to determine if the Spindle Block Servo Controllers on the CT subsystem of potentially affected GEMINI PET/CT systems are susceptible to premature failure.
• Class IITerminated2007-01-09
  When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate.
• Class IITerminated2006-04-25
  Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization application when printing work sheets. this causes information regarding relative locations of marked regions of interest on the patient work sheets to be incorrect and may cause mistrea
• Class IITerminated2005-12-27
  The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this region while the gantry was tilting from an angle to zero tilt angle.

Related

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Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-13. Verify this facility record at FDA →