GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
This recall is currently active, issued December 4, 2024. It was issued by Ge Healthcare (China) Co., Ltd. 1F-5F Bld 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China.
- Recall Initiated
- November 5, 2024
- Posted
- December 4, 2024
- Recall Number
- Z-0604-2025
- Quantity
- 10 units
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide distribution.
Lot / Code Info
UDI/DI 00195278385215, Serial/Sales Order Numbers: CBDLG2400031HM, CBDLG2400035HM, CBDLG2400034HM, CBDLG2400038HM, CBDLG2400036HM, CBDLG2400033HM, CBDLG2400037HM, CBDLG2400032HM, CBDLG2400039HM, CBDLG2400040HM
Root Cause
Component design/selection
Action Taken
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.