Philips Medical Systems Nederland B.V. recalled 461 Allura Xper FD20 Biplanes sold to healthcare facilities nationwide and internationally. X-ray imaging may not initiate or may occur intermittently when using the wired foot switch. Hospitals should stop using the devices immediately and follow Philips’ recall 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 FD20 Biplane is a interventional radiology imaging system used in hospitals for fluoroscopy and X-ray procedures. It is distributed to healthcare facilities worldwide.
The wired foot switch can fail to initiate X-ray imaging or may do so intermittently, potentially delaying or interrupting imaging during procedures.
This recall is not part of a broader industry pattern.
Hospitals must halt use of affected devices, which could disrupt scheduling and patient care during procedures, and may require reallocation of imaging resources.
System Code and System Serial Numbers are printed on the device labeling and service documentation. The recall notice is posted by the FDA and Philips.
Recall processing and remediation may take several weeks. Expect guidance on replacement or repair within 4-6 weeks.
Keep copies of recall notices, communications, serial-number lists, and internal escalation logs for audits and insurance purposes.
Model numbers: (1) System Code: 722008; (2)722013. System Serial Numbers: 360, 361, 445, 296, 487, 390, 306, 178, 420, 267, 245, 2470, 491, 113, 386, 69, 413, 365. Sold to healthcare facilities nationwide and internationally. Domestic US distribution: 198 units. International distribution: 263 units. Price: Not disclosed.
No injuries or incidents have been reported.
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