Philips Medical Systems Nederland B.V. recalls 1,523 Azurion 7 B20 interventional X-ray systems used by hospitals nationwide after possible failure to initiate X-ray imaging. The defect affects whether imaging starts when using the wired foot switch. Hospitals should stop using the device and follow Philips recall instructions immediately.
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 B20 is an interventional radiology X-ray system used for guided procedures in hospitals.
A wired foot switch may fail to initiate X-ray imaging or trigger intermittent imaging during procedures, potentially impacting patient care.
This recall is not described as part of a broader industry pattern.
Hospitals must stop using affected systems and coordinate with Philips for service or replacement; patient care workflows may be disrupted.
Device labeling and service documentation show System Code and UDI
Recall instructions should be followed. Timeline for replacement or service will vary by facility.
Keep copies of recall notification, communications with Philips, and service records
Model codes: System Code 722068, 722226, 722236. UDI: 00884838085367. System Serial Numbers include 547, 178, 467, 335, 147, 205, 170, 455, 494, 564, 418, 95, 440, 247, 225, 64, 149, 42. Sold to hospitals and healthcare facilities nationwide. Sold since unknown. Price not disclosed.
No injuries or incidents have been reported.
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