Philips Medical Systems Nederland B.V. recalled 5 Allura Xper FD20/20 OR Tables distributed nationwide and internationally after detecting intermittent X-ray activation with the wired foot switch. The defect can prevent X-ray imaging from starting or cause it to stop during procedures. Hospitals and clinicians should stop using the affected tables and await manufacturer guidance.
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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Model numbers: System Code 722039; UDI 00884838054271; System Serial Numbers: 4, 2, 5, 8, 6. Where sold: Domestic nationwide distribution and international distribution to hospitals and surgical centers. When sold: Unknown. Price: Unknown.
The wired foot switch may fail to initiate X-ray imaging or cause intermittent activation. This could lead to imaging not occurring during procedures or stopping unexpectedly, potentially impacting patient care.
No injuries or incidents have been reported.
1. Stop using the product. 2. Follow recall instructions provided by the manufacturer. 3. Contact Philips Medical Systems Nederland B.V. or your healthcare provider for instructions. 4. For instructions and any potential refund considerations, contact Philips Medical Systems Nederland B.V.
Manufacturer: Philips Medical Systems Nederland B.V. Recall contact details not provided in the summary. Refer to the FDA enforcement page for the official notice.
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