Z-1900-2021Class II

Revolution EVO, Optima CT660, Optima CT680 CT Systems

Name: Z-1900-2021 Revolution EVO, Optima CT660, Optima CT680 CT Systems
Creator: GE Healthcare, LLC
Published: 2021-06-14
License: https://open.fda.gov/license/

GE Healthcare / initiated 2021-06-14 / Open, Classified / root cause: software

FDA source

GE Healthcare, LLC began a recall of Revolution EVO, Optima CT660, Optima CT680 CT Systems on 2021-06-14. FDA classified it as Class II and gives the reason as "Improperly loaded software options may result in additional X -ray radiation exposure to the patient". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1900-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-06-14
Posted: 2021-06-25
Recalling firm: GE Healthcare
Product: Revolution EVO, Optima CT660, Optima CT680 CT Systems.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Improperly loaded software options may result in additional X -ray radiation exposure to the patient.
Root cause tag: software
FDA root cause: Radiation Control for Health and Safety Act
Action: GE Healthcare will send an Important Electronic Product Radiation Warning letter to all affected systems informing its users of the potential for the issue to occur and instruct the users as to what actions to take to prevent this issue.
Quantity in commerce: 3665
Distribution: 3,665 (US = 956; OUS = 2,709)
Product codes and lots: Optima CT660 12HW28.8 14HW30.3 15HW25.2 13HW38.14 15HW13.7 Revolution EVO 14HW17.4 15HW13.7 Optima CT680 13HW38.14 15BW21.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1900-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1900-2021	Class II	Ongoing	FDA Mandated	2021-07-07	2021-06-25

Product code JAK

K131576Class IIOptima Ct660Ge Medical Systems, LLC / cleared 2013-08-30

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)