Stephanix

Activity by year

Devices registered here (3)

• System, X-Ray, Angiographic
  Product code IZI (opens in a new tab) · Class II · Radiology · 21 CFR 892.1600
• System, X-Ray, Fluoroscopic, Image-Intensified
  Product code JAA (opens in a new tab) · Class II · Radiology · 21 CFR 892.1650
• Interventional Fluoroscopic X-Ray System
  Product code OWB (opens in a new tab) · Class II · Radiology · 21 CFR 892.1650

Recalls & enforcement

• Class IIOngoing2025-06-10
  Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
• Class IIOngoing2024-01-22
  Potential interference with the anti-fall system.
• Class IIOngoing2023-12-13
  Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
• Class IIOngoing2023-05-23
  There is a software login in issue that may prevent the user from logging in.
• Class IIOngoing2023-02-06
  Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
• Class IIOngoing2022-08-12
  Due to un-commanded movement of mobile x-ray unit.
• Class IIOngoing2021-10-14
  While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in the system moving on i…
• Class IIOngoing2018-07-18
  A safety problem with installation and maintenance could lead to the breakage of the two steel cables that support the equipment to its roof anchor. Due to this, the equipment may fall and cause harm to the patient, user, or third parties.
• Class IITerminated2016-01-18
  This is related to previous 806 Notifications about uncommanded movements of a motorized mobile x-ray system. Reason for Recall: Along with the previously noted encoder and gauges problems and corresponding fixes, we have observed that static electricity can also elicit the unwan…
• Class IITerminated2015-07-13
  Electrostatic energy may be stored in Systems that can cause a short-cicuit which, in turn, can generate an Electomagnetic Pulse which might disturb the electronics of the Digital Motion Control Board producing uncontrolled movements and such uncontrolled movements could cause th…
• Class IITerminated2014-08-06
  Reports of unexpected movement.

FDA inspections (1)

• VAI2023-09-14
  Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

• Warning Letter2016-08-12
  Warning Letter (opens in a new tab) · La Ricamarie

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Related

• All facilities operated by SEDECAL S.A.
• A.T.S. Applicazione Tecnologie Speciali s.r.l. (IT)
• SEDECAL S.A. (ES)
• Metaltronica Spa (IT)

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)