Optima CT580
by GE Hangwei Medical Systems Company Ltd.
Optima CT580 is a Class II device made by GE Hangwei Medical Systems Company Ltd., cleared under FDA 510(k) K132410 on 17 Jan 2014 (1 earlier submission) and listed in FDA GUDID since 8 Jun 2016 (UDI-DI 00840682102513), active as of 23 Oct 2026. 5 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
2 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00840682102513 | Date8 Jun 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK132410 | Date17 Jan 2014 | StatusActive |
Official records
- AccessGUDID record 00840682102513
- FDA 510(k) database K132410
- FDA 510(k) database K093581
Across registries
- FDA 510(k) K132410 decided 17 Jan 2014 Active
- FDA GUDID UDI-DI 00840682102513 listed 8 Jun 2016 Listed
Recalls
-
- Ongoing Z-0600-2025
- Ongoing Z-0613-2025
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.
-
- Terminated Z-2581-2018
Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
-
- Terminated Z-2184-2017
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
-
- Terminated Z-1245-2014
GE Healthcare has recently become aware of a potential safety issue due to a software issue associated with the Head Scan Protocols used on your Optima CT580 or Discovery CT590RT scanner. A potential hazardous situation may occur during a CT head scan causing a novel and rare artifact that may hide pathology. When using the head and large head SFOV, which applies the Iterative Bone Option (IBO)
Timeline
- Cleared FDA 510(k) K093581
- Cleared FDA 510(k) K132410
- Recall initiated FDA recalls Z-1245-2014
- Listed FDA GUDID 00840682102513
- Recall initiated FDA recalls Z-2184-2017
- Recall initiated FDA recalls Z-2581-2018
- Recall initiated FDA recalls Z-0600-2025
- Recall initiated FDA recalls Z-0613-2025
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Optima
- Generic name
- Full-body CT system
- Model / reference
- CT580
- Primary DI / UDI-DI
- 00840682102513
- FDA product code
- JAK
- GMDN term
- Full-body CT system
- Device class
- Class II
- Regulation number
- 892.1750
- GUDID distribution status
- In Commercial Distribution
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