Philips Medical Systems recalled 501 Allura Xper FD20 Biplane systems on September 3, 2025. The BIOS battery may deplete quickly, halting system startup without warning. The recall affects devices distributed worldwide, including the US and several countries in Europe and Asia.
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
The recall involves Allura Xper FD20 Biplane systems with model numbers 722008 and 722013. The devices were distributed internationally, including 212 units in the US and 289 units overseas.
The BIOS battery may deplete faster than expected, causing the system to stop functioning. Users receive no prior warning before the battery fails.
No specific incidents or injuries have been reported related to this recall. The potential for operational failure poses a significant risk to patient safety.
Stop using the Allura Xper FD20 Biplane immediately. Contact Philips Medical Systems or your healthcare provider for further instructions.
For more information, call Philips Medical Systems at their contact number or visit their website for guidance.
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