Lower riskMedical device recall · FDA · Published February 7, 2021
GE Healthcare NM/CT 8:00 Scanners May Cause Radiation Shift - Recall
GE Healthcare recalls NM/CT 860 scanners that may shift CT radiation exposure by up to 5cm, risking extra X-rays during specific scans. Affected units sold with GTIN 00840682140751.
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.
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Contact the company
📍Recalling firmGE Healthcare, LLC3000 N Grandview Blvd · Waukesha, WI 53188-1615
✎ GovInfoNow plain-language explainer
GE Healthcare is recalling NM/CT 860 scanners that could shift radiation exposure by up to 5cm during specific scans, potentially requiring extra X-rays. This affects patients undergoing certain imaging procedures with the hybrid whole-body continuous F3 protocol. Read more at govinfonow.com/recall/63296-ge-healthcare-nm-ct-8-00-scanners-may-cause-radiation.
“GE Healthcare NM/CT 8:00 Scanners May Cause Radiation Shift - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63296-ge-healthcare-nm-ct-8-00-scanners-may-cause-radiation. Based on FDA recall #Z-1546-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1546-2021%22&limit=1).
The FDA announced on Feb. 7, 2021, that GE Healthcare is recalling NM/CT 860 Nuclear Medicine / CT Scanners due to a potential radiation exposure shift. The agency issued the Class II recall for devices distributed worldwide.
How to tell if you have it
GE Healthcare NM/CT 860 Nuclear Medicine / CT Scanners
GTIN*00840682140751
The hazard
According to the FDA, the issue may cause a shift in CT radiation exposure range of up to 5cm compared to the intended range under specific workflows. This error 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 necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.
Context
GovInfoNow's records show GE Healthcare LLC has 97 other recalls on record since Oct. 4, 2017. Other recent recalls include GE Healthcare SIGNA Premier MRI Scanners (Feb. 27, 2026), GE Centricity Universal Viewer 6.0/7.0/8.0 (July 15, 2022), and another SIGNA Premier recall (June 24, 2022). Other recent recalls of similar products include Philips Brilliance CT 64 Medical Scanner Recall (Aug. 7, 2026), Philips Ingenuity CT Scanners (Aug. 7, 2026), and Philips IQon Spectral CT Software 4.7.7.x Recall (Aug. 7, 2026).
How to tell if you have this one
Check for the NM/CT 860 scanner model with GTIN 00840682140751. The issue occurs only with the hybrid whole-body continuous F3 protocol when Zoom settings are below 1.
Brand
GE Healthcare
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide
Recall number
Product, codes & lots
Z-1545-2021
NM/CT 850 Nuclear Medicine / CT Scanners; GTIN*00840682140775
Z-1546-2021
NM/CT 860 Nuclear Medicine / CT Scanners; GTIN*00840682140751
Z-1547-2021
NM/CT 870 DR Nuclear Medicine / CT Scanners; GTIN*00840682140836
Based on the official FDA remedy
What to do — step by step
Check Scanner Settings
Verify if your scanner uses the hybrid whole-body continuous F3 protocol with Zoom settings below 1.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1546-2021 (February 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1546-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.