Class IIOngoingZ-2134-2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20. Fluoroscopic X-Ray System.
Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
PHILIPS MEDICAL SYSTEM…Jul 30, 2025
Interventional Fluoroscopic X-Ray System recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 133–144 of 183 recalls
Class IIOngoingZ-2101-2025
Medtronic Navigation, Inc.-Boxborough recalls O-arm O2 Imaging System. Mobile X-Ray System.
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
Medtronic Navigation,…MAJul 16, 2025
Class IIOngoingZ-2022-2025
Siemens Medical Solutions USA, Inc recalls interventional fluoroscopic x-ray system
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails.…
Siemens Medical Soluti…PAJul 9, 2025
Class IIOngoingZ-2021-2025
Siemens Medical Solutions USA, Inc recalls interventional fluoroscopic x-ray system
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails.…
Siemens Medical Soluti…PAJul 9, 2025
Class IIOngoingZ-2020-2025
Siemens Medical Solutions USA, Inc recalls interventional fluoroscopic x-ray system
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails.…
Siemens Medical Soluti…PAJul 9, 2025
Class IIOngoingZ-2019-2025
Siemens Medical Solutions USA, Inc recalls ARTIS is a family of dedicated angiography systems developed for single and biplane di…
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails.…
Siemens Medical Soluti…PAJul 9, 2025
Class IIOngoingZ-1969-2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion R1.x and R2.x systems
A software issue was identified in the internal communication process between the system software and the X-ray generator firmware.…
PHILIPS MEDICAL SYSTEM…Jun 18, 2025
Class IIOngoingZ-1583-2025
Philips Medical Systems Nederland B.V. recalls Zenition 70. The device is to be used in health care facilities both inside and outside…
Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
Philips Medical System…Apr 30, 2025
Class IIOngoingZ-1582-2025
Philips North America LLC recalls Veradius Unity. Product Code 718132. The devices are used for radiological guidance and…
A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
Philips North America…MAApr 30, 2025
Class IIOngoingZ-1581-2025
Philips North America LLC recalls Zenition 70. Product Code 718133. The devices are used for radiological guidance and vi…
A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
Philips North America…MAApr 30, 2025
Class IIOngoingZ-1580-2025
Philips North America LLC recalls Zenition 50. Product Code 718096. The devices are used for radiological guidance and v…
A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
Philips North America…MAApr 30, 2025
Class IOngoingZ-1161-2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Cardio Vascular-Allura Centron
Possibility of the patient falling from the table related to the mattress used on the patient table.
PHILIPS MEDICAL SYSTEM…Feb 26, 2025