Philips Medical Systems Nederland B.V. recalls 53 units of the Allura Xper CV20 system due to a BIOS battery that may deplete faster than designed. The recall affects units distributed worldwide, including the US and many other countries. The failure prevents system startup with no prior warning messages.
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 CV20 is a medical imaging system used in clinical environments. It is valued for diagnostic imaging capabilities.
A BIOS battery may deplete faster than designed. This can halt startup without warning, preventing device operation when needed.
This recall is not explicitly described as part of a broader industry pattern.
Affects healthcare operations relying on the imaging system; no injuries reported yet but startup failure could disrupt patient care.
FDA recall page Z-0014-2026 and manufacturer communications
Not specified; expect manufacturer guidance and potential repair options within weeks
Keep recall letter, log communications with Philips, maintain device service records
Model Numbers: 722031. Associated 510(k) numbers: K102005, K130638, K130842, K133292, K141979, K162859, K161563. Quantity: 53 units (OUS only). Distribution: Worldwide, including US nationwide and many countries listed.
No specific injuries or incidents are reported in the provided data.
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