Official recall notice
FDA DeviceClass IINotable
FDA Recall: Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);
- Recall date
- 2026-04-08
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Recommended action
What to do
798 units (42 US, 756 OUS)
Product description
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.