Philips Medical Systems Nederland B.V. recalls Allura Xper FD20 Biplane OR Table models 722020 and 722025. Four units are affected worldwide, including two in the United States. The BIOS battery may deplete faster than expected, halting the system startup with no user warning. The recall advises stop-use and coordination with healthcare providers for instructions.
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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Allura Xper FD20 Biplane OR Table is used in surgical imaging suites to position patients during procedures. It is part of Philips' interventional radiology suite lineup and supports fluoroscopy-based guidance.
A BIOS battery deterioration can prevent the system from starting, potentially delaying or interrupting clinical procedures without prior alerts.
This recall is not described as part of a broader industry pattern in the provided data.
Hospitals and clinics may experience delays or need for workarounds when routine startup fails. No injuries are reported yet.
Recall details are listed on the FDA enforcement page for recall Z-0007-2026 and in manufacturer notices.
Replacement or remedy timelines are not specified; expect direct guidance from Philips via official recall letters.
Keep the recall notice, model numbers, serial numbers, and all correspondence with the manufacturer. Record procedure impact and any downtime.
Product: Allura Xper FD20 Biplane OR Table. Model numbers: 722020 and 722025. Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563. Quantity: 4 units (2 US, 2 outside the US). Distribution: Worldwide. Sold around the timeframes associated with the devices' regulatory clearances. Manufacturer: Philips Medical Systems Nederland B.V.
No injuries or incidents have been reported.
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