CLASS II ONGOING Device recall · Reported 11 Dec 2024 · FDA Enforcement Report
GE Healthcare Operator Console Upgrade Types recalled
GE Healthcare (China) Co is recalling GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China. The recall was initiated on 5 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0615-2025
- FDA event ID
- 95704
- Recalling firm
- GE Healthcare (China) Co, Beijing
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Nov 2024
- FDA classified
- 4 Dec 2024
- Reported
- 11 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 5 Nov 2024 | Recall initiated by company | |
| 4 Dec 2024 | Classified by FDA | +29 days |
| 11 Dec 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT
Where it was distributed
Worldwide distribution.
Questions about this recall
Is GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China recalled?
Yes. GE Healthcare (China) Co recalled GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China on 5 Nov 2024. The recall is Class II and its status is Ongoing. Recall number Z-0615-2025.
Why was it 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.
Which lots are affected?
UDI/DI 00840682102490, Serial/Sales Order Numbers: 5476353, 5472107, 5472476
Where was it sold?
Worldwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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