Philips Medical Systems Nederland recalled 501 Allura Xper FD20 Biplane devices sold worldwide to hospitals and healthcare facilities. The BIOS battery may deplete faster during design, halting the startup and preventing the system from starting with no user messages. Healthcare providers and patients should stop using the device and follow the recall instructions from Philips.
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
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 FD20 Biplane is an interventional radiology imaging system used during catheter-based vascular or neuro interventions. It relies on a BIOS battery to boot. The battery controls startup sequencing.
If the BIOS battery depletes, startup cannot proceed and the device may not power on. The recall notes that no user messages appear before power depletion.
This recall is not presented as part of a broader industry pattern.
Hospitals may experience procedure delays or rescheduling due to startup failures. The immediate safety impact is the potential for a non-operational imaging system during critical procedures.
Serial numbers and UDI-DI are on the device nameplate and service records.
Next steps will be communicated by letter from Philips; replacement or remediation timelines will be provided at that time.
Keep the recall letter, model and serial numbers, and all correspondence with Philips and hospital administration.
Model Numbers: 722008; 722013 510(k) numbers: K102005, K130638, K130842, K133292, K141979, K162859, K161563 Serial numbers affected (sample): 491, 489, 360, 325, 142, 125, 312, 319, 82, 192, 244, 453, 306, 116, 124, 18270 UDI-DI: 722008 N/A; 722013 00884838059061 Quantity: 501 units (212 US, 289 outside US) Distribution: Worldwide distribution to US nationwide and many countries Recall date: 2025-09-03 Brand: Philips Medical Systems Nederland B.V. (standardized as Philips Medical Systems Nederland) Product type: Allura Xper FD20 Biplane Price: Unknown
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 is recalling 798 Azurion 3 M15 systems worldwide, including 42 units in the United States. The wired foot switch may fail to initiate X-ray imaging or fail to produce consistent imaging. Healthcare providers should stop using the affected devices and follow recall instructions issued by Philips.
Philips Medical Systems Nederland B.V. recalls 4 units of the Allura Xper FD20 Biplane OR Table after identifying intermittent or failed X-ray initiation when using the wired foot switch. The recall covers System Codes 722020 and 722025. Healthcare facilities were notified by letter. Stop using the affected devices and follow Philips instructions.
Philips Medical Systems Nederland B.V. recalled 5 Allura Xper FD20/20 OR Tables distributed nationwide and internationally after detecting intermittent X-ray activation with the wired foot switch. The defect can prevent X-ray imaging from starting or cause it to stop during procedures. Hospitals and clinicians should stop using the affected tables and await manufacturer guidance.
Philips Medical Systems Nederland recalled 5,167 Azurion 7 M20 X-ray imaging systems sold to healthcare facilities in the U.S. and internationally. The wired foot switch can fail to initiate imaging or produce intermittent imaging. Hospitals and clinics should stop using the device and follow recall instructions from Philips, with notification by letter to affected parties.
Philips Medical Systems Nederland recalled 174 Allura Xper FD20 OR Tables worldwide, including 45 in the United States. The devices may deteriorate internally, rendering motorized movements inoperable. Hospitals and clinics should stop using the devices and follow the manufacturer's recall instructions.
Philips Medical Systems Nederland recalled 2,317 Allura Xper FD10 imaging systems worldwide, including 497 in the United States. The BIOS battery may deplete faster than expected, causing the startup process to halt with no user alerts. Hospitals should stop using the devices and await manufacturer instructions.
Philips Medical Systems Nederland recall 115 Allura Xper FD20/20 imaging systems worldwide after reports that the BIOS battery may deplete prematurely. The startup process may halt with no user alert. Hospitals and providers should stop using affected units and await manufacturer instructions.