Revolution CT systems with the SmartStep Option recallZ-0776-2019 · GE Healthcare, LLC · initiated Jul 12, 2018
Class II Open, Classified All recalls posted in February 2019
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
On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation and on the gantry display may not be the actual location of the table and result in the system scanning at a location that is not what was confirmed by the operator
FDA root cause category: Software design
What the company is doing
GE Healthcare sent a Notification letter dated October 18, 2018 to affected customers and sent a second letter dated October 30, 2018. The letters identified the affected product, problem and actions to be taken. The customers were instructed to do the following: ensure that all potential users in your facility are made aware of this notification and the recommended action, also stated: To avoid the issue, only use the 'In' button on the gantry controls and follow this required workflow: 1. Move the table back into the gantry using the 'In' button on the gantry controls . 2. Verify that the needle position is aligned using the internal laser alignment light. GE Healthcare will correct both forward production and impacted customer devices with a software update. For question contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall details
- Recall number
- Z-0776-2019
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jul 12, 2018
- Posted by the FDA
- Feb 6, 2019
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 131 units
- Product code
- JAK
- FDA submissions
- K133705, K163213
- Distribution
- Worldwide Distribution - US (Nationwide Distribution) and countries of: Australia, Belgium, Canada, Estonia, Finland, France, Germany, Hong Kong, Ireland, Japan, Korea Republic of, Malaysia, Morocco, New Zealand, Norway, Saudi Arabia, Singapore, Slovakia, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and United Kingdom.
Product description
Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Code information (models, lots, serial numbers)
SmartStep Option
Other devices under the same FDA submission
2 devices cleared under K133705, K163213 — 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 CT ESGE Medical Systems, L.L.C. · System, x-ray, tomography, computed5 recalls0 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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