FDA (Devices) recall action 90446
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of the Overhead Tube Crane (OTC).
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.
Arcoma AB is recalling 71 Omnera 400T radiographic systems because liquid ingress in the display handles may cause electrical short circuits and uncontrolled movement of the overhead tube crane.
Arcoma AB recalls 47 Omnera 400A Digital Radiographic Systems due to potential electrical short circuits that could cause uncontrolled movement of the overhead tube crane.