Optima Advance
by GE Hangwei Medical Systems Company Ltd.
Optima Advance is a Class II device made by GE Hangwei Medical Systems Company Ltd., cleared under FDA 510(k) K123596 on 8 Feb 2013 and listed in FDA GUDID since 23 Jan 2020 (UDI-DI 00840682147415), 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 | Number00840682147415 | Date23 Jan 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK123596 | Date8 Feb 2013 | StatusActive |
Official records
- AccessGUDID record 00840682147415
- FDA 510(k) database K123596
Across registries
- FDA 510(k) K123596 decided 8 Feb 2013 Active
- FDA GUDID UDI-DI 00840682147415 listed 23 Jan 2020 Listed
Recalls
-
- Ongoing Z-0604-2025
- Ongoing Z-0601-2025
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-2585-2018
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-2185-2017
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
-
- Terminated Z-0840-2014
There is an issue with the Manual Film Composer feature on some CT products. There is an opportunity, while following a specific workflow, to create a film image with one patient's images and another patient's name in the footer. This is also an issue when within Manual Film Composer, if a color image is selected for printing, another patient's black and white image appears in the preview screen
Timeline
- Cleared FDA 510(k) K123596
- Recall initiated FDA recalls Z-0840-2014
- Recall initiated FDA recalls Z-2185-2017
- Recall initiated FDA recalls Z-2585-2018
- Listed FDA GUDID 00840682147415
- Recall initiated FDA recalls Z-0604-2025
- Recall initiated FDA recalls Z-0601-2025
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
- Advance
- Primary DI / UDI-DI
- 00840682147415
- 510(k) Number
- 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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