FDA Medical Device Recalls (openFDA)
GE Healthcare (China) Co., Ltd.: GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system
- Recall number
- Z-0611-2025
- Recalling firm
- GE Healthcare (China) Co., Ltd.
- Product
- GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system
- Status
- Open, Classified
- Initiated
- 2024-11-05
- Posted
- 2024-12-04
- Terminated
- not on file
- Reason
- GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.
- Root cause
- Component design/selection
- Action
- GE HealthCare issued an URGENT MEDICAL DEVICE notice to its consignees on 11/05/2024 via mailing using a traceable means. The notice explained the issue, potential safety issue, and requested the following actions be taken: " You can continue to use your system. When utilizing helical, cine, and cardiac scan modes, review the image data set for any potential rotation. When using these modes during interventional procedures or radiation therapy planning, adhere to standard clinical quality checks and workflows. If image rotation is detected, consult with the physician to determine whether a rescan is necessary or if the images need to be corrected during post-processing to ensure accurate interpretation and planning. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." A GE HealthCare representative will contact the consignee to arrange for the correction. For questions or concerns: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
- Quantity
- 3 units
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- UDI/DI 0019527856860, Serial/Sales Order Numbers: CBDOG2400029HM, CBDOG2400031HM, CBDOG2400030HM
- 510(k) numbers
- ["K192686"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 3008284470
- Firm city
- Beijing
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28