Philips recalled 1,994 Azurion 7 M12 interventional X-ray systems, including 360 units in the United States, for a wiring-foot switch defect that may fail to initiate imaging. The issue can cause imaging to not start or operate intermittently. Hospitals and clinicians should stop using affected devices immediately and follow the manufacturer’s 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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Model codes: (1) 722078, (2) 722223, (3) 722233. UDI: 00884838085251. System Serial Number: 302. Additional identifiers include: 585, 410, 753, 523, 293, 840, 291, 536, 537, 870, 613, 598, 679, 224, 829, 249, 546. Sold/distributed: Domestic nationwide and international distribution to Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Botswana, Brazil, Canada, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Germany, Ghana, Greece, Guatemala,H
X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. The defect could affect crucial diagnostic imaging during procedures. The recall emphasizes immediate action to stop use and seek guidance from Philips or a healthcare provider.
No injuries or incidents have been reported.
1. Stop using the product. 2. Contact Philips Medical Systems Nederland B.V. or your healthcare provider for instructions. 3. Follow the recall instructions included in the notification letter. 4. Arrange for replacement or service as directed by Philips. 5. Refer to the contact information below for remediation details.
Phone: Unknown. Website: Unknown. Hours: Unknown.
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