FDA (Devices) recall action 71842
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.
Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.
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 PET Discovery LS scanners because the power supply may be expelled, posing a safety risk.
GE Healthcare is recalling 416 Lightspeed 16 CT scanners worldwide because the power supply may be expelled from the unit.
GE Healthcare is recalling 18 PET Discovery ST 16 scanners because the power supply may be expelled. The recall covers units distributed in the US and 30 other countries.