FDA (Devices) recall action 98434
The FDA (Devices) publishes a recall like this one as 22 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 22 pages.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Philips is recalling the Azurion 3 M15 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Philips is recalling the Allura Xper FD10/10 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Philips is recalling the Allura Xper FD20/15 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Philips is recalling the Allura Xper FD10 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Philips is recalling the Azurion 5 M12 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Philips is recalling the Allura Xper FD10C because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Philips is recalling the Azurion 7 B20 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Philips is recalling the Allura Xper FD10 OR Table because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Philips is recalling the Azurion 7 M12 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Philips is recalling the Azurion 3 M12 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Philips is recalling the Azurion 7 B12 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Philips is recalling the Allura Xper FD20 Biplane OR Table because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Philips is recalling the Allura Xper FD20/10 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Philips is recalling the Allura Xper FD20/20 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Philips is recalling the Allura Xper FD10F because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Philips is recalling the Allura Xper FD20/20 OR Table because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Philips is recalling the Allura Xper FD20 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Philips is recalling the Allura Xper FD20 OR Table because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Philips is recalling the Allura Xper FD20/15 OR Table because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Philips has identified instances where X-ray imaging on the Azurion 7 M20 may not initiate, or may run intermittently, when the wired foot switch is used. 5,167 units are affected.
Philips is recalling the Allura Xper FD20 Biplane because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Philips is recalling the Azurion 5 M20 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.