FDA (Devices) recall action 77377
The FDA (Devices) publishes a recall like this one as 16 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 16 pages.
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
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 10,884 Optima CT540 X-ray systems because a software issue may cause scans to start before a prescribed delay completes.
GE Healthcare is recalling 10,884 LightSpeed VCT X-ray systems because a defect may cause scans to start before the prescribed delay completes.
GE Healthcare is recalling Discovery ML DR X-ray systems because a software issue may cause scans to start before a prescribed delay completes.
GE Healthcare is recalling 10,884 Discovery ML X-ray systems because a defect may cause scans to start before a prescribed delay completes.
GE Healthcare is recalling 10,884 BrightSpeed X-ray systems because a defect may cause scans to start before a prescribed delay completes.
GE Healthcare is recalling Discovery NM/CT 670 CZT X-ray systems because a defect may cause scans to start before the prescribed delay completes.
GE Healthcare is recalling 10,884 Innova IGS 540 ACT X-ray systems because a software issue may cause scans to start before a prescribed delay completes.
GE Healthcare is recalling Optima CT520 X-ray systems because a defect may cause scans to start before a prescribed delay completes.
GE Healthcare is recalling 10,884 Lightspeed RT16 X-ray systems because a defect may cause scans to start before a prescribed delay completes.
GE Healthcare is recalling Discovery NM/CT 670 X-ray systems because a defect may cause scans to start before a prescribed delay completes.
GE Healthcare is recalling 10,884 Revolution EVO X-ray systems because a defect may cause scans to start before a prescribed delay completes.
GE Healthcare is recalling 10,884 Discovery NM/CT 570c X-ray systems because a defect may cause scans to start before the prescribed delay completes.
GE Healthcare is recalling Discovery IQ X-ray systems because a software issue may cause scans to start before a prescribed delay completes.
GE Healthcare is recalling Optima CT660 and CT680 X-ray systems because a defect may cause scans to start before a prescribed delay completes.
GE Healthcare is recalling PET/CT X-ray systems because a defect may cause scans to start before a prescribed delay completes.
GE Healthcare is recalling Optima CT580 and Discovery RT CT590 RT X-ray systems because scans may start before the prescribed delay completes.