Philips Medical Systems Nederland B.V. recalls 10 Allura Xper FD10F imaging systems sold to hospitals worldwide. The devices may fail to start X-ray imaging or start intermittently when using the wired foot switch. Hospitals should stop using the devices immediately and contact Philips for instructions.
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 FD10F is a medical fluoroscopy system used in interventional radiology to image the body during procedures.
A wired foot switch fault may prevent X-ray imaging from starting or cause intermittent imaging, potentially delaying diagnosis or treatment.
This recall is not part of a broader industry pattern.
Hospitals may need to halt procedures using the affected systems and arrange for recall-based remediation. No reported injuries to date.
System Code label and System Serial Number tag on the equipment; UDI is listed as N/A.
Recall notice does not specify remediation timeline.
Document recall notice receipt, serial numbers, and communications with Philips and hospital risk management.
Product: ALLURA Xper FD10F, System Code 722002 Quantity: 10 units (8 US, 2 overseas) Sold in: Domestic nationwide distribution; International distribution to Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, China, Colombia, Costa Rica, Denmark, Egypt, France, Germany, India, Ireland, Israel, Italy, Japan, Jordan, Kenya, Malaysia, Mexico, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Romania, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Ukraine, United Kingdom, United Arab Emirates, United States,
No injuries or incidents have been reported.
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