Use cautionMedical device recall · FDA · Published November 23, 2020
GE Healthcare Revolution CT ES X-ray Scanner Recall: Protocol Errors Risk Patient Safety
GE Healthcare recalls Revolution CT ES X-ray scanners due to potential protocol errors causing patient safety risks. Affected units have specific model and serial numbers. Consumers should contact GE for details.
“GE Healthcare Revolution CT ES X-ray Scanner Recall: Protocol Errors Risk Patient Safety.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63801-ge-healthcare-revolution-ct-es-x-ray-scanner-recall-protocol. Based on FDA recall #Z-0694-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0694-2021%22&limit=1).
The FDA announced on 2020-11-23 that GE Healthcare LLC voluntarily recalled two Revolution CT ES units due to a potential for unintended patient orientation or scan settings when using Intelligent Protocoling, according to the FDA.
How to tell if you have it
GE Healthcare
Revolution CT ES
Model Number: 5995001-6
Serial Number's: REVV81900024CN (System ID:561955REV/UDI: 01008406821234711119070021REVV81900024CN)
Serial Number's: REVV81900022CN (System ID: DPN80000/ UDI:01008406821234711119070021REVV81900022CN)
The hazard
The recall cites a potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling, according to the FDA.
Context
GovInfoNow's records show GE Healthcare LLC has 97 other recalls on record since 2017-10-04. Other recent recalls of similar products include GE Healthcare SIGNA Premier MRI Scanners May Have Steel Fittings Risking Injury (2026-02-27), GE Centricity Universal Viewer 6.0/7.0/8.0: Inaccurate Distance Measurements (2022-07-15), and GE Healthcare SIGNA Premier MRI Scanner Recall: Risk of Hearing Loss from Acoustic Noise (2022-06-24). Other recent recalls of similar products include GE Healthcare Centricity PACS Server V7 Recall: Risk of Wrong Patient Images (2026-07-31), GE Revolution CT ES Security Vulnerability Recall: Potential Data Exposure (2026-03-26), and Philips Brilliance CT 64 Medical Scanner Recall: Unintended Radiation Risk (2026-08-07).
How to tell if you have this one
Check for model number 5995001-6 on the scanner. Serial numbers include REVV81900024CN and REVV81900022CN with specific system IDs.
Brand
GE Healthcare
Category
Medical device
FDA recall event · 2 products
All 2 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
Terminated
Distribution
Worldwide distribution - US Nationwide distribution including in the states of FL and TX. The countries of Belgium, France, and Spain.
Recall number
Product, codes & lots
Quantity
Z-0694-2021
Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.; Model Number: 5995001-6; Serial Number's: REVV81900024CN (System ID:561955REV/UDI: 01008406821234711119070021REVV81900024CN) and REVV81900022CN (System ID: DPN80000/ UDI:01008406821234711119070021REVV81900022CN).
2 units
Z-0695-2021
Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.; Model Number: 5995000-5; Serial Number's: REVVX1700078CN (System ID: 713MMREVCT/UDI: 01008406821185521117070021REVVX1700078CN) , 00000440315CN0 (System ID: 220078CT04), and REVVX1800040CN (System ID: M2322265/UDI: 01008406821185521118030021REVVX1800040CN).
3 units
Based on the official FDA remedy
What to do — step by step
Contact GE Healthcare
Reach out to GE Healthcare for specific recall details and instructions for affected units.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of FL and TX. The countries of Belgium, France, and Spain.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Texas.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0694-2021 (November 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0694-2021 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.