Revolution CT
This recall has been completed (originally issued July 8, 2021).
- Company
- Ge Healthcare, Llc
- Recall Initiated
- March 19, 2021
- Posted
- July 8, 2021
- Recall Number
- Z-2004-2021
- Quantity
- 197 (US = 40; OUS = 157)
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide
Lot / Code Info
5590000 5590000-6 5590000-2
Root Cause
Radiation Control for Health and Safety Act
Action Taken
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.