Philips recalls 298 Azurion 3 M12 X-ray imaging systems used by healthcare providers worldwide. The issue is that X-ray imaging may not start or may be intermittent when using the wired foot switch. Stop using the affected devices immediately and follow 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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Azurion 3 M12 is a interventional X-ray imaging system used in hospitals for guidance during procedures.
A failure or intermittent operation of the imaging function can affect diagnostic or procedural outcomes.
This recall is not stated as part of a broader industry pattern.
Hospitals may experience procedure delays or imaging downtime until devices are serviced or replaced.
Check device label and the recall notice for system codes, UDI, and serial numbers
Philips will provide remediation instructions; timelines vary by region
Keep recall letter, device identifiers, service reports, and all correspondence with Philips for records
System Codes: (1)722063, (2)722221, (3)722229. UDI: 00884838085275. System Serial Number: 122. Additional identifiers include: 56, 64, 131, 84, 132, 96, 98, 108, 77, 82, 145, 47, 146, 80, 102, 43, 117. Quantity: 298 units (27 US, 271 OUS). Distribution: Domestic nationwide; International in numerous countries. Sold through healthcare facilities worldwide. Recall date: 2026-03-03. Status: Active.
No injuries or incidents have been reported.
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