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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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.
The wired foot switch may fail to initiate X-ray imaging or may do so intermittently. The issue can disrupt diagnostic procedures and patient care.
No injuries or incidents have been reported.
1. Stop using the product. 2. Contact Philips Medical Systems Nederland B.V. or your healthcare provider for instructions. 3. Follow the recall notification for next steps. 4. Report any affected device to your hospital safety officer.
Notification method: Letter. Brand: Philips Medical Systems Nederland B.V. No consumer phone line is listed in the recall notice. Website: refer to Philips Healthcare recall materials. Hours: Unknown.
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