Recall Z-0601-2025— GE Healthcare (China) Co., Ltd.
Class II · Ongoing
Class II FDA medical device recall by GE Healthcare (China) Co., Ltd., initiated 2024-11-05. It names one FDA 510(k) clearance: K123596. Product: GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems. 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..
- Recalling firm
- GE Healthcare (China) Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-11-05
- Firm location
- Beijing, China
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.