Philips Medical Systems Nederland B.V. recalled 2 Allura Xper FD10C imaging systems in the United States. The BIOS battery may deplete faster during design, halting startup without warning. Hospitals should stop using the device and follow the manufacturer’s recall 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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The Allura Xper FD10C is a medical imaging system used in interventional radiology. It assists physicians in conducting vascular and neurological procedures.
A BIOS battery that depletes faster than expected can stop the system from starting, potentially delaying patient imaging.
This recall is not described as part of a broader industry pattern in the provided notice.
Hospitals may need to halt procedures until an update or replacement is arranged, which can affect patient throughput and scheduling.
Recall notices are posted on FDA enforcement pages and the Philips recall communications portal.
Recall resolution timelines vary; hospitals typically expect guidance within weeks to months for replacement or service.
Document all communications with the sponsor and any fault reports; preserve device labels and serials for audit.
Model number: 722001. Associated 510(k) numbers: K102005, K130638, K130842, K133292, K141979, K162859, K161563. Sold worldwide; 2 units recalled in the US. Price: Unknown.
No injuries or incidents have been reported.
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