Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported December 11, 2024
GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ge Healthcare (China) Co., Ltd. recalled GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system - a moderate-severity action.
GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system was recalled by Ge Healthcare (China) Co., Ltd. in December 11, 2024. Reason: GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT system…. Check the official notice for the remedy. Verify recall #Z-0602-2025 with the FDA Devices before acting.
The recall
Ge Healthcare (China) Co., Ltd. issued this moderate-severity FDA Devices recall-GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT system….
- Moderate
- severity level
- 8 units
- affected scope
- Class II
- classification
- December 11, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0602-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0602-2025) was formally reported on December 11, 2024, with the manufacturer initiating the action on November 5, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Ge Healthcare (China) Co., Ltd. is listed as the recalling firm, operating out of Beijing. Federal records list the affected scope as 8 units.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Worldwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
8 units
Related Recalls
6
3 from same agency
Product description
GE Healthcare Optima 680 Expert, Model number 6670000; 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0602-2025 |
| Date reported | December 11, 2024 |
| Date initiated | November 5, 2024 |
| Recalling firm | Ge Healthcare (China) Co., Ltd. |
| Firm location | Beijing |
| Affected scope | 8 units |
| Distribution | Worldwide distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0602-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system. Recalled by Ge Healthcare (China) Co., Ltd.. Units affected: 8 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on December 11, 2024. Severity: Moderate. Recall number: Z-0602-2025.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0602-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 11, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.