GE Healthcare Revolution CT., multi-slice (256 detector… recallZ-0985-2015 · GE Healthcare · initiated Dec 19, 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
Potential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. No injuries or illnesses reported.
FDA root cause category: Process control
What the company is doing
Consignees were sent on 12/19/2014 a GE Healthcare "Urgent Medical Device Correction" letter GEHC # 25457 dated December 19, 2014. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology / Cardiology and Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (US phone 800-437-1171, Japan 0120-055-919, other countries contact your local GE Healthcare Service Representative).
Recall details
- Recall number
- Z-0985-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 19, 2014
- Posted by the FDA
- Jan 15, 2015
- Recalling firm
- GE Healthcare
- Quantity
- 13 (7 US, 6 OUS)
- Product code
- JAK
- FDA submissions
- K133705
- Distribution
- US: FL, WA, IL, UT, NY, CA. OUS: Canada, France, Hong Kong, Japan, Switzerland, United Arab Emirates.
Product description
GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.
Code information (models, lots, serial numbers)
Mfg Lot or Serial # System ID 00000437461CN7 519646REVO1 00000437837CN8 M2322254 00000438342CN8 828210096 00000437028CN4 REV001 00000438864CN1 900010CT06 00000439199CN1 260010CT19 00000439068CN8 AE1477CT01 00000437787CN5 786596WKRIVO 00000438503CN5 206598REV1 00000438951CN6 309655REVCT 00000439029CN0 801662REV1 00000439160CN3 212241REVCT 00000439367CN4 415476MCT3
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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