Recall Z-0857-2021 ยท KPS System, Tomography, Computed, Emission
GE Healthcare, LLC
Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Product Usage: intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such NM System: General Nucle
| 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 | 52 untits |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093514 | DISCOVERY MODEL NM/CT 670 Ge Medical Systems F.I. Haifa, Dec 10, 2009 |