Philips Medical Systems Nederland B.V. recalled 300 Allura Xper FD20/15 devices on September 3, 2025. The BIOS battery may deplete too quickly, halting system start-up. Users may not receive any warning before the battery fails.
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
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The recall affects model number 722058 with associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563. The devices were sold worldwide, including in the U.S. and various countries.
The BIOS battery may deplete faster than expected, causing the device to fail to start. Users will not receive any alerts regarding low battery levels.
There have been no specific injury reports associated with this recall. The potential hazard poses a significant risk to patient safety.
Stop using the Allura Xper FD20/15 immediately. Contact Philips Medical Systems or your healthcare provider for further instructions.
For more details, visit Philips at www.accessdata.fda.gov or call your local healthcare provider for assistance.
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