FDA DeviceClass IINotable
FDA Recall: Azurion 5 M12; System Code: (1)722227, (2)722231;
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
345 units (10 US, 335 OUS)
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