Philips Medical Systems Nederland B.V. recalled 286 Allura Xper FD10/10 fluoroscopy systems worldwide, including 67 US units. Deterioration of internal components such as the CMOS battery, hard disk drive, and power supply can disable motorized system movements. Hospitals and other healthcare providers should stop using affected devices and follow the manufacturer’s recall instructions.
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. or your healthcare provider for instructions. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The Allura Xper FD10/10 is a fluoroscopy system used in interventional radiology to perform X-ray guided procedures. It is distributed to hospitals and clinics worldwide.
Internal components may deteriorate over time, causing loss of motorized movement. The imaging function remains accessible, but automated positioning may fail, impacting procedural workflow.
This recall is not described as part of a broader industry pattern in the notice.
Hospitals must assess inventory and service continuity. Device downtime could delay procedures and complicate operating room scheduling.
Serial numbers and model identifiers are on the device data plate and user manuals.
Vendor will provide replacement or repair instructions; processing timelines depend on facility procurement.
Document device model, serial number, recall notice date, communications with manufacturer, and any downtime impact.
Product: Allura Xper FD10/10 fluoroscopy system. Models: 722011, 722027, 722005. Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949. Sold worldwide to hospitals and clinics, including 67 US units and 219 outside the US. Recall date: 2025-09-03. Country of origin: Netherlands.
No injuries or incidents have been reported.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
Philips Medical Systems Nederland B.V. recalled 3,552 Vue Motion V12 devices worldwide, including the United States. The recall is due to a potential that mis-ordered frames during dynamic cine runs may display out of sequence. Stop using the device and follow the recall instructions provided by the manufacturer.
Philips Medical Systems Nederland B.V. recalls 2 ALLURA Xper FD10 OR Tables after reports that X-ray imaging may not start or may delay when using the wired foot switch. The defect could affect patients during imaging procedures. Healthcare providers should stop using the device and follow recall instructions from the manufacturer.
Philips Medical Systems Nederland B.V. recalls 111 Allura Xper FD20/20 imaging systems with System Code 722038. The recall covers 31 units in the United States and 80 abroad. The defect may prevent X-ray imaging from starting or cause intermittent imaging when using the wired foot switch. Stop using the device immediately and follow recall instructions from Philips or your healthcare provider.
Philips Medical Systems Nederland B.V. recalled 345 Azurion 5 M12 X-ray systems distributed worldwide after reports that X-ray imaging may not start or may run intermittently when using the wired foot switch. The defect could affect imaging during patient care. Hospitals should stop using the device immediately and follow the recall instructions in the notification letter.
Philips recalls 298 Azurion 3 M12 X-ray imaging systems used by healthcare providers worldwide. The issue is that X-ray imaging may not start or may be intermittent when using the wired foot switch. Stop using the affected devices immediately and follow recall instructions from Philips.
Philips Medical Systems Nederland B.V. recalled 920 Azurion 5 M20 imaging systems worldwide, including 168 in the United States. The recall cites a defect in which X-ray imaging may not start or may begin intermittently when using the wired foot switch. Healthcare providers should stop using the device immediately and await instructions from Philips.
Philips recalled 112 ALLURA Xper FD10/10 imaging systems nationwide in the United States and internationally after reports that X-ray imaging may not start or may intermittently stop when using the wired foot switch. The defect affects system codes 722005, 722011, and 722027. Healthcare providers should stop using the devices and follow Philips recall instructions.
Philips Medical Systems Nederland B.V. recalled 5,084 ALLURA Xper FD20 imaging systems sold nationwide and internationally after finding that the wired foot switch may fail to initiate X-ray imaging or perform intermittently. The defect can delay or interrupt imaging during patient care. Healthcare facilities should stop using the devices and follow the manufacturer’s recall instructions.