Philips Medical Systems Nederland B.V. recalled 15 Allura Xper FD10C radiography systems worldwide, including 7 in the United States and 8 overseas. The devices may fail to initiate X-ray imaging or intermittently stop imaging when using the wired foot switch. Facilities should stop using the devices and await recall instructions from Philips.
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 FD10C is a radiography system used in clinical imaging. It is designed to produce X-ray images for diagnostic purposes. The recall concerns a wired foot switch that may fail to initiate imaging or do so intermittently.
The defect can prevent imaging from starting or cause imaging to stop unexpectedly. This may delay diagnosis or compromise image acquisition.
This recall is not described as part of a broader industry-wide pattern in the provided information.
Immediate device cessation is required. Healthcare facilities may need to replace or service units and manage imaging workflow disruptions.
Recall letters, the FDA recall page, and Philips customer service for device-specific identifiers.
Remedies and timelines will be provided by Philips in the recall communications. No specific 4- to 8-week window is stated in the notice.
Document the recall notice, store all correspondence with manufacturer, and retain device labels showing System Code and serial numbers.
Product: Allura Xper FD10C X-ray imaging system. Model identifiers include System Code 722001 and associated serial numbers listed in the recall notice. Quantity recalled: 15 units (7 in the US, 8 outside the US). Distribution: Domestic nationwide and international across a long list of countries. Manufacturer: Philips Medical Systems Nederland B.V.
No injuries or incidents have been reported.
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