Recall Z-0858-2021 ยท KPS System, Tomography, Computed, Emission
GE Healthcare, LLC
Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
| Date | Dec 10, 2020 |
| Status | Terminated |
| Reason | GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector. |
| Root cause | Process control |
| Action | The firm initiated their action by letter to the consignees on 12/10/2020. The letter explained the issue and stated that GE would inspect, and if required, correct the affected units. Questions and concerns may be directed to GE Healthcare Service at 1-800-437-1171 or the consignee's local Service Representative. |
| Quantity | 7 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121019 | OPTIMA NM/CT 640 GE Healthcare, Apr 19, 2012 |