GE Healthcare Revolution Advance recall
GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
Why was GE Healthcare Revolution Advance recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 00195278385215, Serial/Sales Order Numbers: CBDLG2400031HM, CBDLG2400035HM, CBDLG2400034HM, CBDLG2400038HM, CBDLG2400036HM, CBDLG2400033HM, CBDLG2400037HM, CBDLG2400032HM, CBDLG2400039HM, CBDLG2400040HM
- Product
- GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
- Recalling firm
- GE Healthcare (China) Co., Ltd.
- Quantity
- 10 units
- Distribution
- Worldwide distribution.
- Recall date
- December 11, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)