FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: Revolution CT
- Recall number
- Z-2004-2021
- Recalling firm
- GE Healthcare, LLC
- Product
- Revolution CT
- Status
- Completed
- Initiated
- 2021-03-19
- Posted
- 2021-07-08
- Terminated
- not on file
- Reason
- GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- GE Healthcare will perform an initial site assessment and replace the collimator, if needed. This will be followed by bi-weekly remote monitoring of the system s log file. Finally, GE Healthcare will install a currently under development software patch, added to the daily fast calibration to automatically and reliably detect this failure should it occur. All of these actions will be performed at no cost to the customer. For questions call 262-544-3217.
- Quantity
- 197 (US = 40; OUS = 157)
- Distribution
- Worldwide distribution - US Nationwide
- Lot, serial or model codes
- 5590000 5590000-6 5590000-2
- 510(k) numbers
- ["K133705","K163213","K191777"]
- 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