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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare

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 Class 2 Device Recall GE Healthcaresee related information
Date Initiated by FirmNovember 05, 2024
Date PostedDecember 04, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0602-2025
Recall Event ID 95704
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductGE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system
Code Information UDI/DI 00840682146937, Serial/Sales Order Numbers: CBDXG2400054HM, CBDXG2400059HM, CBDXG2400055HM, CBDXG2400058HM, CBDXG2400057HM, CBDXG2400060HM, CBDXG2400061HM, CBDXG2400056HM
Recalling Firm/
Manufacturer		 GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China
For Additional Information ContactGE HealthCare Service
800-437-1171
Manufacturer 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.
FDA Determined
Cause 2		Component design/selection
ActionGE 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 in Commerce8 units
DistributionWorldwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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