Philips Medical Systems Nederland B.V. recalled 920 Azurion 5 M20 imaging systems worldwide, including 168 in the United States. The recall cites a defect in which X-ray imaging may not start or may begin intermittently when using the wired foot switch. Healthcare providers should stop using the device immediately and await 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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Quick reference: - Product: Azurion 5 M20 Interventional Imaging System - System Codes: 722228, 722232, 722281 (OUS) - UDI: 00884838099234 - Quantity: 920 units total (168 US, 752 OUS) - Countries: Domestic US distribution and international distribution across numerous countries - Manufacturer: Philips Medical Systems Nederland B.V. (Netherlands)
The device may fail to initiate X-ray imaging or may start intermittently when using the wired foot switch. This could affect real-time imaging during procedures.
No injuries or incidents have been reported.
1. Stop using the product. 2. Follow the recall instructions provided by Philips. 3. Contact Philips Medical Systems Nederland B.V. or your healthcare provider for instructions. 4. Notification is by recall letter.
Manufacturer: Philips Medical Systems Nederland B.V. Recall page: FDA enforcement report Z-1680-2026 Notes: Contact through the official recall notification method.
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