Philips Medical Systems Nederland B.V. recalls 5,067 Allura Xper FD20 imaging systems worldwide. The BIOS battery may deplete faster than planned, causing the system to fail to start. The issue affects 1,626 US and 3,441 international units. Customers should stop using affected devices 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 is a medical imaging system used in clinical settings for diagnostic procedures. It provides critical imaging capabilities in hospital environments.
A rapidly depleting BIOS battery can prevent system startup without prior user alerts, potentially delaying patient imaging.
This recall is not presented as part of a broader industry pattern in the provided data.
Immediate cessation of use is required. Hospitals must coordinate with Philips for guidance. No injuries have been reported yet.
Refer to manufacturer letters and FDA recall page for details on identifiers
Refund/replacement timelines not specified; follow manufacturer instructions
Document recall notice, correspondence with Philips, and any replacement steps
Product: Allura Xper FD20. Model numbers: 722006, 722012, 722028. Associated 510(k) numbers: K102005, K130638, K130842, K133292, K141979, K162859, K161563. Quantity: 5,067 units (1,626 US, 3,441 international). Distribution: Worldwide.
No injuries or incidents have been reported in the provided data.
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