Computed Tomography Systems recallZ-0242-2022 · GE Healthcare, LLC · initiated Jun 30, 2021
Class II Open, Classified All recalls posted in November 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
The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table height is adjusted after the exam starts. In this situation, the SmartStep display will show a value that is higher (up to 100 times) than the actual dose delivered.
FDA root cause category: Radiation Control for Health and Safety Act
What the company is doing
GE sent an Important Electronic Product Radiation Warning Notification letter dated October 4, 2021 to customers, The letter identified the affected product, problem and actions to be taken. Customers were informed that GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you or through a GE Healthcare field engineer site visit. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall details
- Recall number
- Z-0242-2022
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jun 30, 2021
- Posted by the FDA
- Nov 24, 2021
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 105 in total
- Product code
- JAK
- FDA submissions
- K133705, K163213, K191777
- Distribution
- Worldwide and US Nationwide Distribution
Product description
Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
Code information (models, lots, serial numbers)
Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
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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