Philips Medical Systems Nederland B.V. recalls 2 ALLURA Xper FD10 OR Tables after reports that X-ray imaging may not start or may delay when using the wired foot switch. The defect could affect patients during imaging procedures. Healthcare providers should stop using the device and follow recall instructions from the manufacturer.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
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 FD10 OR Table is used in operating rooms to position patients for radiographic imaging during procedures.
A wired foot switch may fail to initiate X-ray imaging or may do so intermittently, potentially delaying imaging during procedures.
This recall is not described as part of a broader industry pattern in the notice.
For hospitals, this may cause procedure delays and require device replacements or repairs, with potential workflow disruptions.
Refer to FDA enforcement page linked in the recall notice
Remedies typically completed within 4-8 weeks after recall initiation
Keep the recall letter, take photos of the device labels, preserve any correspondence with manufacturer or hospital, and log serial numbers and system codes.
Model numbers and codes: (1) System Code 722022, UDI 00884838059078, System Serial Number 6; (2) System Code 722033, UDI 00884838054233, System Serial Number 1. Sold worldwide with domestic nationwide distribution and international distribution to many countries. Quantity recalled: 2 units. Manufacturer: Philips Medical Systems Nederland B.V.
No injuries or incidents have been reported.
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