Revolution Apex, Revolution CT with Apex Edition recallZ-0815-2022 · GE Healthcare, LLC · initiated Jun 30, 2021
Class II Open, Classified All recalls posted in April 2022
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. There are two situations that will result in the SmartStep displayed dose being inaccurately high.
FDA root cause category: Radiation Control for Health and Safety Act
What the company is doing
GE Healthcare sent an Important Electronic Product Radiation Warning letter dated February 8, 2022 to all affected systems informing its users of the potential for the issue to occur and instruct the users as to what actions to take. 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 Services at 1 (800) 437-1171 or local Service Representative.
Recall details
- Recall number
- Z-0815-2022
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jun 30, 2021
- Posted by the FDA
- Apr 5, 2022
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 273 (51 US, 222 OUS) in total
- Product code
- JAK
- FDA submissions
- K163213, K191777
- Distribution
- Worldwide - US Nationwide distribution.
Product description
Revolution Apex, Revolution CT with Apex Edition
Code information (models, lots, serial numbers)
Revolution Apex, Revolution CT with Apex Edition
Other devices under the same FDA submission
4 devices cleared under 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 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
Other products in the same recall event
The FDA groups related products into one recall event (event 89762).
- Z-0816-2022 · Open, ClassifiedRevolution CT, Revolution CT ES
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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