FDA (Devices) recall action 70924
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.
An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.
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.
GE Healthcare is recalling six Brivo XR285amx mobile X-ray units in the US due to potential inaccuracies in mAs accuracy checks.
GE Healthcare is recalling six Optima XR200 amx mobile X-ray units in the US due to potential mAs accuracy issues that may affect exposure times.
GE Healthcare is recalling six Optima XR220 amx mobile X-ray units in the US due to potential mAs accuracy inaccuracies.