NM/CT 870 DR Nuclear Medicine / CT Scanners
FDA device recall Z-1547-2021 · posted 2021-05-11 · Open, Classified
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- KPS
- Quantity affected
- 242 in total (17 units US)
- Distribution
- Worldwide distribution - US Nationwide
- Date initiated
- 2021-02-07
- Date posted
- 2021-05-11
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISCOVERY MODEL NM/CT 670 (K093514) | Ge Medical Systems F.I. Haifa | 2009-12-10 |