FDA DeviceClass IINotable
FDA Recall: Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
Description
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Hazard
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Remedy
920 units (168 US, 752 OUS)
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