Philips recalls 670 Azurion 7 B12 X-ray imaging systems after finding the wired foot switch may fail to start imaging. The issue affects 106 US units and 564 in other countries. Hospitals should stop using the device 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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The Azurion 7 B12 is an interventional X-ray imaging system used in hospital procedure rooms to guide minimally invasive interventions.
A defect in the wired foot switch can prevent X-ray imaging from starting or cause intermittent operation, compromising procedural imaging.
This recall is not noted as part of a broader industry pattern.
Hospitals may experience imaging delays during procedures. The recall covers 670 units across many countries and requires immediate action to prevent workflow disruption and potential patient safety risk.
On device data plate, user manual, or installation documentation for System Code, UDI, and Serial Numbers.
Remediation timelines vary by region; Philips will issue instructions and facilitate service or replacement as needed.
Keep the recall notification, record all serial numbers and statuses, preserve any replacement or service tickets, and photograph data plates for records.
Product: Azurion 7 B12 Interventional X-ray Imaging System System Codes: 722067, 722225, 722235 UDI: 00884838085350 System Serial Numbers: 221, 42, 172, 173, 109, 250, 103, 192, 92, 114, 225, 69, 214, 41, 98, 81, 123, 278 Quantity recalled: 670 total (106 US, 564 OUS) Domestic distribution: Nationwide International distribution: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Côte d’Ivoire, Croatia,
No injuries or incidents have been reported.
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