Philips Medical Systems Nederland B.V. recalled 345 Azurion 5 M12 X-ray systems distributed worldwide after reports that X-ray imaging may not start or may run intermittently when using the wired foot switch. The defect could affect imaging during patient care. Hospitals should stop using the device immediately and follow the recall instructions in the notification letter.
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 is Philips’ family of interventional imaging systems used in radiology suites for real-time X-ray guided procedures. The Azurion 5 M12 is one model within that family. Healthcare facilities deploy these systems to perform diagnostic and therapeutic procedures.
The defect may prevent X-ray imaging from starting or cause intermittent imaging when using the wired foot switch, potentially delaying diagnosis and treatment.
This recall is not described as part of a broader industry pattern.
Hospitals may need to halt use of the affected devices and reallocate imaging work. The recall could impact patient throughput and procedure scheduling while replacements or service arrangements are arranged.
Look for the recall notification letter and the FDA recall page linked in the notice.
Remediation timelines vary by hospital and supplier; expect several weeks for replacement or service arrangements.
Keep the recall letter, serial numbers, system codes, and all correspondence. Photograph the device label and store communications for records
Model numbers and identifiers include System Code 722227 and 722231. UDI is 00884838099227. System Serial Numbers include 265 and 135, 88, 276, 264, 271, 63, 238, 360, 23, 127, 159, 197, 149, 54, 56, 230, 192. Domestic and international distribution is listed below.
No injuries or incidents have been reported.
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