GE Healthcare, LLC NM/CT 850 Nuclear Medicine / CT Scanners Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NM/CT 850 Nuclear Medicine / CT Scanners
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
GTIN*00840682140775
Products Sold
GTIN*00840682140775
GE Healthcare, LLC is recalling NM/CT 850 Nuclear Medicine / CT Scanners due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026