FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
- Recall number
- Z-1951-2019
- Recalling firm
- GE Healthcare, LLC
- Product
- Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
- Status
- Open, Classified
- Initiated
- 2019-01-19
- Posted
- not on file
- Terminated
- not on file
- Reason
- Additional low dose radiation exposure.
- Root cause
- Device Design
- Action
- GE Healthcare will send a customer letter that provide safety instructions for immediate mitigation of the issue. The customer can continue to use the system with the recommended workaround instruction provided in the customer letter: All affected systems will be corrected with updated software and a User Manual Addendum which re-emphasizes existing pat ient center ing instructions. If you have any questions or concerns regarding this notification. For question contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Quantity
- 857 (US = 195: OUS = 662)
- Distribution
- Worldwide - US Nationwide Distribution
- Lot, serial or model codes
- Revolution CT
- 510(k) numbers
- ["K133705","K163213"]
- 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