The Revolution CT is a multi-slice (256 detector row) CT… recallZ-0955-2015 · GE Healthcare · initiated Nov 12, 2014
Class II Terminated All recalls posted in January 2015
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 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
A required quality control test was not performed during installation associated with the software of the Revolution CT scanner.
FDA root cause category: Radiation Control for Health and Safety Act
What the company is doing
GE Healthcare Planned Action (s) to repair defect or to bring product into Compliance letter dated January 16, 2015 to GE Healthcare. 1. A GE Healthcare service representative will perform a noise specification and tolerance calibration to correct all affected systems via Field Action Instruction (FMI 25457). 2. A customer notification letter which includes a statement that GE Healthcare will without charge, remedy the defect or bring the product into compliance. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. GE Healthcare Surgery will implement this CAP by May 1, 2015. You may proceed or continue with implementation of the CAP (subject to the conditions noted above). Call Center phone numbers: United States: 800 437-1171, Japan: 0120-055-919 Information For other countries, please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification.
Recall details
- Recall number
- Z-0955-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 12, 2014
- Posted by the FDA
- Jan 26, 2015
- Recalling firm
- GE Healthcare
- Quantity
- 13 units
- Product code
- JAK
- FDA submissions
- K133705
- Distribution
- US Distribution to the states of CA, FL, IL, NY, UT and WA.
Product description
The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.
Code information (models, lots, serial numbers)
Software version: 14MW14.29
Other devices under the same FDA submission
1 device cleared under K133705 — 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
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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