Philips Medical Systems Nederland B.V. recalled 585 units of the Allura Xper FD10/10 diagnostic system globally, including 145 in the United States, after reports that the BIOS battery can deplete faster than expected and halt system startup. The recall covers models 722005, 722011, and 722027. Healthcare facilities should stop using the device and follow manufacturer instructions for remediation.
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 FD10/10 is a diagnostic imaging system used in clinical settings for X-ray based procedures.
A BIOS battery that depletes sooner than expected can prevent the system from starting, potentially delaying diagnostic imaging.
This recall is not described as part of a broader industry pattern in the provided data.
Immediate halt could halt imaging procedures, potentially affecting patient care and workflow.
Refer to the recall notice and manufacturer documentation for UDI, serial number, and model information.
Remediation or replacement guidance will be provided by Philips; expect timelines to be communicated with the recall notice.
Keep copy of the recall notice, correspondence with Philips, serial numbers, model numbers, UDI-DI, and any replacement or remediation receipts.
Product: Allura Xper FD10/10. Models: 722005, 722011, 722027. Associated 510(k) numbers: K102005, K130638, K130842, K133292, K141979, K162859, K161563. Serial numbers include 361, 212, 233, 321, 435, 285, 384, 388, 343, 399, 392, 128, 355, 51. UDI-DI: 00884838059047 for 722011 and 00884838054196 for 722027. Quantity: 585 units total (145 US, 440 outside the US). Distribution: Worldwide.
No injuries or incidents have been reported in the provided data.
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