Z-0603-2025Class II

GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems

Name: Z-0603-2025 GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems
Creator: GE Healthcare (China) Co., Ltd.
Published: 2024-11-05
License: https://open.fda.gov/license/

GE Healthcare (China) Co., Ltd. / initiated 2024-11-05 / Open, Classified / root cause: design

FDA source

GE Healthcare (China) Co., Ltd. began a recall of GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems on 2024-11-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0603-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-05
Posted: 2024-12-04
Recalling firm: GE Healthcare (China) Co., Ltd.
Product: GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems
Product code: JAK System, X-Ray, Tomography, Computed
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: GE HealthCare issued an URGENT MEDICAL DEVICE notice to its consignees on 11/05/2024 via mailing using a traceable means. The notice explained the issue, potential safety issue, and requested the following actions be taken: " You can continue to use your system. When utilizing helical, cine, and cardiac scan modes, review the image data set for any potential rotation. When using these modes during interventional procedures or radiation therapy planning, adhere to standard clinical quality checks and workflows. If image rotation is detected, consult with the physician to determine whether a rescan is necessary or if the images need to be corrected during post-processing to ensure accurate interpretation and planning. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." A GE HealthCare representative will contact the consignee to arrange for the correction. For questions or concerns: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 5 units
Distribution: Worldwide distribution.
Product codes and lots: UDI/DI 00840682146159, Serial/Sales Order Numbers: CBDAG2400021HM, CBDAG2400023HM, CBDAG2400024HM, CBDAG2400020HM, CBDAG2400022HM

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0603-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0600-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-04
Z-0601-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-04
Z-0602-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-04
Z-0603-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-04
Z-0604-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-04
Z-0605-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-04
Z-0606-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-04
Z-0607-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-04
Z-0608-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-04
Z-0609-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-04
Z-0610-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-04
Z-0611-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-04
Z-0612-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-04
Z-0613-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-04
Z-0614-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-04
Z-0615-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-04
Z-0616-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-04

Product code JAK

K192686Class IIRevolution Maxima, Revolution AceGe Hangwei Medical Systems Co., Ltd. / cleared 2019-10-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)