RegWardenFDA facility compliance records
Facility

Siemens Healthineers AG Varian Cancer Therapy (CTH)

29 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2011: 1 recalls; 2012: 8 recalls; 2013: 6 recalls; 2014: 4 recalls; 2015: 3 recalls; 2016: 4 recalls; 2018: 2 recalls; 2019: 1 recalls1’118’126’134’143’154’16’172’181’19’20’21’22’23’24’25’26
  • Recalls (29)

Devices registered here (1)

Recalls & enforcement

20191 record
  • Class IITerminated2019-08-12
    After a recent upgrade to the collimator software version 8.5, the firm became aware that the multi-leaf collimator leaves did not move during an arc treatment. The issue is related to a transient carriage primary- secondary interlock due to carriage fault on the MLC that immedia…
20182 records
  • Class IITerminated2018-12-26
    There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Superposition [PCS] dose calculation algorithm. The PCS algo- rithm calculates the water equivalent range incorrectly for non-square 3D CT images (either different number of pixels in X a…
  • Class IITerminated2018-08-20
    Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on more than one system.
20164 records
  • Class IITerminated2016-12-02
    Modifications in version 13.6MR2 for Contouring, SmartAdapt, and SmartSegmentation workspaces resulted in contours not being saved consistently in Eclipse. Treatment Planning System. The issue only occurs if certain conditions are fulfilled.
  • Class IITerminated2016-09-13
    Varian Medical Systems has received a report that a user was able to easily rotate the head frame posts when attached to the mounting cam on the metal head ring. There was no report of serious injury due to this issue
  • Class IITerminated2016-06-23
    Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the plan couch rotation while performing pa…
  • Class IITerminated2016-01-11
    When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments for Eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the calculated Monitor Units (MU). Potential for unintended radiation exposure.
20153 records
  • Class IITerminated2015-09-28
    An anomaly was identified with the ARIA for Radiation Oncology software with a Clinical Assessment license. Admin Instructions may not print on drug order prescriptions or be transmitted with e-Rx.
  • Class IITerminated2015-05-18
    Varian has discovered that there is a discrepancy in the absolute dose rate given with the Leipzig-style Surface Applicator's Instructions for Use (IFU): Dose Characterization GM11010080 2012-09-06. The actual dose rate of the applicator is approximately 14% higher than the …
  • Class IITerminated2015-05-18
    After an application freeze and restart of the VariSource iX series by power cycling, the Partial Fraction generated by the system will not be correct. The application freeze issue affects only the systems equipped with magnetic Hard Disk Drives (HDD).
20144 records
  • Class IITerminated2014-08-18
    Due to user error, the 4DITC can improperly allow users to clear a safety interlock imposed by the 4DITC on behalf of Varian's Bar Code Conical Verification system from the BrainLab's ExacTract console when it is used with BCCV.
  • Class IITerminated2014-06-17
    Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode.
  • Class IITerminated2014-04-30
    Varian MedicalSystems' X-ray generator Supplier (CPI) has identified that 32 VMS150 X-ray Generators were shipped that are missing a ground wire between the EMIbraid on the induc­ tion assembly cable and the ground stud on the lid of the High Voltage Module.
  • Class IITerminated2014-03-20
    Varian has identified a failure with the shaft of the Type 01 elbow motor for Exact arms used in the On-Board Imager (OBI) device due to belt over-tensioning.
20136 records
  • Class IITerminated2013-11-18
    An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and "do no clear MUs and Reference Point dose" is selected, the Monitor units may change.
  • Class IITerminated2013-10-24
    This correction is to notify users that a solution to a previous correction has been developed and Varians reps will be contacting locations to schedule installation.
  • Class IITerminated2013-08-09
    The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after steam sterilization.
  • Class IITerminated2013-04-11
    Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.
  • Class IITerminated2013-03-26
    Varian has identified an anomaly with the RPM Respiratory Gating System version I.7.5 with 3D Option. While operating with the 6-dot marker block, this version of RPM Gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions.
  • Class IITerminated2013-01-28
    The calculation of dose dynamic plans containing different energy fields is incorrect when the Pencil Beam Convolution 11.0 algorithm (PBC 11.0) is used.
20128 records
  • Class IITerminated2012-11-05
    Varian Medical Systems has identified an anomaly with the ARIA Oncology Information System Radiation Oncology [ARIA RO] DICOM import/export functionality where a 360 degree arc field may convert to static field during DICOM export or import.
  • Class IITerminated2012-09-28
    The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.
  • Class IITerminated2012-09-24
    An anomaly has been identified with the ARIA Oncology Information System Version 11 where Monitor Units of one fraction may be incorrect, when partial treatment is being continued.
  • Class IITerminated2012-08-17
    Varian has identified an anomaly with the Eclipse Treatment Planning where an outdated assigned Hounsfield Unit [HU] value can be used for dose calculation when the clock on the Eclipse Client Workstation is not synchronized with the Database/System Server. Treatment of the patie…
  • Class IITerminated2012-08-14
    Some X-jaw (lower collimator jaw) carriers were made using the incorrect metal alloy, which can cause the jaw carrier to crack. If both carriers on the same X-jaw crack, the jaw would be able to move freely in the closed direction. The position readout interlock circuitry will n…
  • Class IITerminated2012-07-02
    A software anomaly has been identified with the Import Export Application version 11.0 where MLC leaf positions for plans using BrainLab m3 and mMLC are incorrectly imported.
  • Class IITerminated2012-06-18
    Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments) where changing the prescription in a calculated VMAT or RapidArc plan may lead to Monitor Units which do not reflect the new prescription. If the dose prescription of a VMAT or Rapi…
  • Class IITerminated2012-04-12
    A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
20111 record
  • Class IITerminated2011-05-31
    Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to about 7% before interlock occurs. At maximum asymmetry, this may result in no more than about 3.5% dose deviation from expect…

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Siemens Healthineers AG Varian Cancer Therapy (CTH) (FEI 3006894636) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006894636-siemens-healthineers-ag-varian-cancer-th/

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