FDA (Devices) recall action 74731
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag
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 993 MultiDiagnost Eleva x-ray systems because bolts may break, causing the C-arm to sag. The recall covers units distributed worldwide.
Philips is recalling 993 MultiDiagnost Eleva x-ray systems because bolts attaching the clamping plate may break, causing the C-arm to sag.
Philips is recalling UroDiagnost x-ray systems because bolts may break, causing the c-arm to move and sag.