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Lower risk Medical device recall · FDA · Published June 14, 2021

GE Healthcare CT Scanners: Risk of Extra X-ray Radiation Exposure

GE Healthcare recalls Revolution EVO, Optima CT660, and Optima CT680 CT systems due to potential increased X-ray radiation exposure from software options. Affected units have specific hardware codes.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1900-2021Medical deviceGE Healthcare ›
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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 three types of CT scanners because software issues might expose patients to extra X-ray radiation. This could mean higher radiation doses during scans, which is a health risk. Read more at govinfonow.com/recall/62342-ge-healthcare-ct-scanners-risk-of-extra-x-ray-radiation.

Source Summary by GovInfoNow · govinfonow.com/recall/62342-ge-healthcare-ct-scanners-risk-of-extra-x-ray-radiation · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1900-2021

Cite this page

“GE Healthcare CT Scanners: Risk of Extra X-ray Radiation Exposure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62342-ge-healthcare-ct-scanners-risk-of-extra-x-ray-radiation. Based on FDA recall #Z-1900-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1900-2021%22&limit=1).

The FDA announced on June 14, 2021, that GE Healthcare LLC is recalling Revolution EVO, Optima CT660, and Optima CT680 CT Systems due to improperly loaded software options that may result in additional X-ray radiation exposure to patients. The agency issued the Class II recall for 3,665 units distributed in the U.S. and overseas.

How to tell if you have it

  • GE Healthcare Revolution EVO
  • GE Healthcare Optima CT660
  • GE Healthcare Optima CT680
  • Optima CT660 12HW28.8
  • Optima CT660 14HW30.3
  • Optima CT660 15HW25.2
  • Optima CT660 13HW38.14
  • Optima CT660 15HW13.7
  • Revolution EVO 14HW17.4
  • Revolution EVO 15HW13.7
  • Optima CT680 13HW38.14
  • Optima CT680 15BW21.2

The hazard

According to the FDA, improperly loaded software options on these CT systems may result in additional X-ray radiation exposure to the patient. The recall classification is Class II.

Context

GovInfoNow's records show GE Healthcare LLC has 97 other recalls on record since October 4, 2017. Other recent recalls include GE Healthcare SIGNA Premier MRI Scanners (February 27, 2026), GE Centricity Universal Viewer 6.0/7.0/8.0 (July 15, 2022), and GE Healthcare SIGNA Premier MRI Scanner (June 24, 2022). Other recent recalls of similar products include Philips Ingenuity CT Scanners (August 7, 2026) and Philips Brilliance CT Scanners (August 7, 2026).

How to tell if you have this one

Check the hardware code on the scanner's label. Affected models include Revolution EVO (14HW17.4, 15HW13.7), Optima CT660 (12HW28.8, 14HW30.3, 15HW25.2, 13HW38.14, 15HW13.7), and Optima CT680 (13HW38.14, 15BW21.2).

  • Brand
    GE Healthcare
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Hardware Code

    Look for the hardware code on the scanner's label to determine if it's affected.

How this recall unfolded

Recall timeline

FDA published this recall 23 days after the firm started it.

1. Firm started the recall: Jun 14, 202112. FDA classified it Class II: Jun 25, 202123. Published in FDA’s Enforcement Report: Jul 7, 202132021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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-1900-2021 (June 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1900-2021 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA