FDA (Devices) recall action 85466
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
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 123 Lunar iDXA Advance bone densitometers because a control panel issue may cause the start button to stick, potentially leading to accidental radiation exposure.
GE Healthcare is recalling 123 Lunar iDXA bone densitometers because a control panel defect may cause the start button to stick, potentially leading to accidental radiation exposure.
GE Healthcare is recalling 123 Lunar iDXA bone densitometers because a control panel defect may cause the start button to stick, potentially leading to accidental radiation exposure.
GE Healthcare is recalling 123 Lunar iDXA bone densitometers because a control panel issue may cause the start button to stick, potentially leading to accidental radiation exposure.