Recall Z-1547-2021 ยท KPS System, Tomography, Computed, Emission
GE Healthcare, LLC
NM/CT 870 DR Nuclear Medicine / CT Scanners
| Date | May 11, 2021 (initiated Feb 7, 2021) |
| Status | Open, Classified |
| Reason | GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation. |
| Root cause | Device Design |
| Action | GE Healthcare will send a customer notification letter describing the issue and providing safety instructions for immediate mitigation of the issue. Customers were instructed, they may continue to use the system and follow workaround instructions (zoom=1 for specific WB protocol) until the correction is provided. GE Healthcare corrective action is the development and deployment of a software update on all affected smart console IB systems at no cost to the customer. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. |
| Quantity | 242 in total (17 units US) |
| Distribution | Worldwide distribution - US Nationwide |
| 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 |