Philips is recalling 798 Azurion 3 M15 systems worldwide, including 42 units in the United States. The wired foot switch may fail to initiate X-ray imaging or fail to produce consistent imaging. Healthcare providers should stop using the affected devices and follow recall instructions issued by 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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Model numbers and identifiers: System Code 722064, 722222, 722230, 722280 (OUS Only). UDI: 00884838085282. System Serial Numbers include 209, 238, 201, 258, 260, 261, 314, 229, 291, 270, 267, 218, 335, 513, 61, 161, 162, 169. Total units recalled: 798 (US: 42; OUS: 756). Distribution: Domestic nationwide in the US and international to Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, CostaR
The wired foot switch may fail to initiate X-ray imaging or may cause imaging to occur intermittently. This can delay or disrupt essential imaging during procedures.
No injuries or incidents have been reported.
1. Stop using the product. 2. Follow the recall instructions provided by Philips and contact your healthcare provider for guidance. 3. Coordinate with your facility for service or replacement as directed by Philips. 4. Await the recall letter and keep records of communications.
Notification method: Letter. For instructions, contact Philips Medical Systems Nederland B.V. or your healthcare provider. FDA recall page: Z-1674-2026.
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