Philips Medical Systems Nederland B.V. recalls 300 units of the Allura Xper FD20/15 with model 722058 after the BIOS battery may deplete prematurely, causing startup failure. The recall covers worldwide distribution. Patients and healthcare providers should stop using the device immediately and follow manufacturer 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 FD20/15 is a medical imaging system used in clinical settings. It helps produce diagnostic images during procedures.
A BIOS battery that depletes faster than expected can prevent the system from starting, leaving facilities without diagnostic capability. There is no user-facing warning before failure.
This recall is not described as part of a broader industry pattern in the provided data.
Hospitals and clinics could experience downtime, requiring immediate action to exchange or repair units and maintain patient care.
Look at the recall notification letter and FDA enforcement page for final instructions
No explicit refund/replacement timeline provided; follow manufacturer guidance
Keep recall letter, model/serial numbers, and replacement receipts
Product: Allura Xper FD20/15. Model Numbers: 722058. Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563. Quantity: 300 units (69 US, 231 outside US). Distribution: Worldwide.
No injuries or incidents have been reported.
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