Official recall notice

FDA DeviceClass IINotable

FDA Recall: Azurion 5 M12; System Code: (1)722227, (2)722231;

Recall date
2026-04-08
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

345 units (10 US, 335 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.

Verify with the official notice →
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