Recall Z-1678-2026— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class II · Ongoing
Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2026-03-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);. Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch..
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-03
- Firm location
- Best, Netherlands
Product description
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
Reason for recall
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Data sourced from openFDA. This site is unofficial and independent of the FDA.