FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: Revolution EVO, Optima CT660, Optima CT680 CT Systems.
- Recall number
- Z-1900-2021
- Recalling firm
- GE Healthcare, LLC
- Product
- Revolution EVO, Optima CT660, Optima CT680 CT Systems.
- Status
- Open, Classified
- Initiated
- 2021-06-14
- Posted
- not on file
- Terminated
- not on file
- Reason
- Improperly loaded software options may result in additional X -ray radiation exposure to the patient.
- 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
- 3665
- Distribution
- 3,665 (US = 956; OUS = 2,709)
- Lot, serial or model codes
- Optima CT660 12HW28.8 14HW30.3 15HW25.2 13HW38.14 15HW13.7 Revolution EVO 14HW17.4 15HW13.7 Optima CT680 13HW38.14 15BW21.2
- 510(k) numbers
- ["K131576"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28