Revolution CT recallZ-2004-2021 · GE Healthcare, LLC · initiated Mar 19, 2021
Class II Completed All recalls posted in July 2021
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 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.
FDA root cause category: Radiation Control for Health and Safety Act
What the company is doing
GE Healthcare will perform an initial site assessment and replace the collimator, if needed. This will be followed by bi-weekly remote monitoring of the system s log file. Finally, GE Healthcare will install a currently under development software patch, added to the daily fast calibration to automatically and reliably detect this failure should it occur. All of these actions will be performed at no cost to the customer. For questions call 262-544-3217.
Recall details
- Recall number
- Z-2004-2021
- Recall class
- Class II
- Status
- Completed
- Initiated by the company
- Mar 19, 2021
- Posted by the FDA
- Jul 8, 2021
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 197 (US = 40; OUS = 157)
- Product code
- JAK
- FDA submissions
- K133705, K163213, K191777
- Distribution
- Worldwide distribution - US Nationwide
Product description
Revolution CT
Code information (models, lots, serial numbers)
5590000 5590000-6 5590000-2
Other devices under the same FDA submission
5 devices cleared under K133705, K163213, K191777 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Revolution CTGE Medical Systems, L.L.C. · System, x-ray, tomography, computed6 recalls0 reports
- Revolution ApexGE Medical Systems, L.L.C. · System, x-ray, tomography, computed6 recalls0 reports
- Revolution CT ESGE Medical Systems, L.L.C. · System, x-ray, tomography, computed5 recalls0 reports
- Revolution Apex PlusGE Medical Systems, L.L.C. · System, x-ray, tomography, computed2 recalls1 report
- Revolution CT with Apex editionGE Medical Systems, L.L.C. · System, x-ray, tomography, computed1 recall0 reports
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 18, 2026. Text above is shown as published by the FDA.
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