FDA (Devices) recall action 86337
The FDA (Devices) publishes a recall like this one as 8 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 8 pages.
Rotor bearing screws were found loose on detector.
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 15 NM/CT 870 CZT systems because rotor bearing screws were found loose on the detector.
GE Healthcare is recalling 20 Discovery 670 DR units because rotor bearing screws were found loose on the detector.
GE Healthcare is recalling 25 NM/CT 850 systems because rotor bearing screws were found loose on the detector.
GE Healthcare is recalling 31 NM/CT 870 DR systems because rotor bearing screws were found loose on the detector.
GE Healthcare is recalling nine Discovery NM670 Pro units because rotor bearing screws were found loose on the detector.
GE Healthcare is recalling 25 NM 830 detectors because rotor bearing screws were found loose. The devices are distributed in the US and internationally.
GE Healthcare is recalling four NM/CT 860 SPECT/CT systems because rotor bearing screws were found loose on the detector.
GE Healthcare is recalling 62 Discovery NM 630 systems because rotor bearing screws were found loose on the detector.