Use cautionMedical device recall · FDA · Published March 19, 2021
GE Healthcare Revolution CT Recall: Radiation Dose Risk
GE Healthcare recalls Revolution CT systems due to potential radiation dose inaccuracies. Affected units may deliver higher or lower radiation than prescribed, risking patient safety.
GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.
Take action
Contact the company
📍Recalling firmGE Healthcare, LLC3000 N Grandview Blvd · Waukesha, WI 53188-1615
“GE Healthcare Revolution CT Recall: Radiation Dose Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63027-ge-healthcare-revolution-ct-recall-radiation-dose-risk. Based on FDA recall #Z-2004-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2004-2021%22&limit=1).
The FDA announced on March 19, 2021, that GE Healthcare LLC is recalling Revolution CT systems due to a potential collimator blade issue. This defect could cause delivered x-ray radiation doses to be larger or smaller than prescribed values.
How to tell if you have it
Brand: GE Healthcare
Product: Revolution CT
Model numbers: 5590000, 5590000-6, 5590000-2
The hazard
GE Healthcare identified a potential issue where a collimator blade on the Revolution CT system does not find its appropriate home position. This malfunction could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.
Context
GovInfoNow's records show GE Healthcare LLC has 97 other recalls on record since October 4, 2017. Other recent recalls include a February 27, 2026 recall of SIGNA Premier MRI Scanners for steel fitting risks and a July 15, 2022 recall of Centricity Universal Viewer 6.0/7.0/8.0 for inaccurate distance measurements. Recent similar product recalls include an August 7, 2026 Philips Brilliance CT 64 Medical Scanner recall and an August 7, 2026 Philips Ingenuity CT Scanners recall, both citing unintended radiation risks.
How to tell if you have this one
Check for the model numbers 5590000, 5590000-6, or 5590000-2 on the Revolution CT system. These units were sold by GE Healthcare.
Brand
GE Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check System Model
Identify your Revolution CT system's model number to confirm if it is affected.
Contact GE Healthcare
Reach out to GE Healthcare for guidance on next steps if your unit is affected.
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 4 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-2004-2021 (March 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2004-2021 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.