NMCT recallZ-1546-2021 · GE Healthcare, LLC · initiated Feb 7, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1546-2021
- Status
- Open, Classified
- Initiated by the company
- Feb 7, 2021
- Posted by the FDA
- May 11, 2021
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 242 in total (17 units US)
- Product code
- KPS
- FDA submissions
- K173816
- Distribution
- Worldwide distribution - US Nationwide
Product description
NM/CT 860 Nuclear Medicine / CT Scanners
Code information (models, lots, serial numbers)
GTIN*00840682140751
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NMCT 860G E Medical Systems Israel Ltd. · System, tomography, computed, emission2 recalls0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K173816 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- NMCT 850G E Medical Systems Israel Ltd. · System, x-ray, tomography, computed2 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 87811).
- Z-1545-2021 · Open, ClassifiedNM/CT 850 Nuclear Medicine / CT Scanners
- Z-1547-2021 · Open, ClassifiedNM/CT 870 DR Nuclear Medicine / CT Scanners
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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