Z-0605-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 11, 2024
- Initiation Date
- November 5, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 units
Product Description
GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system
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 Pattern
Worldwide distribution.
Code Information
UDI/DI 00840682146173, Serial/Sales Order Numbers: CBDWG2400109HM, CBDWG2400103HM, CBDWG2400102HM, CBDWG2400096HM, CBDWG2400111HM, CBDWG2400106HM, CBDWG2400115HM, CBDWG2400113HM, CBDWG2400105HM, CBDWG2400112HM, CBDWG2400116HM, CBDWG2400114HM, CBDWG2400107HM, CBDWG2400104HM, CBDWG2400110HM, CBDWG2400108HM