Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
This recall is currently active, issued January 19, 2019. It was issued by Ge Healthcare, Llc.
- Company
- Ge Healthcare, Llc
- Recall Initiated
- January 19, 2019
- Recall Number
- Z-1951-2019
- Quantity
- 857 (US = 195: OUS = 662)
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
Reason for Recall
Additional low dose radiation exposure.
Distribution
Worldwide - US Nationwide Distribution
Lot / Code Info
Revolution CT
Root Cause
Device Design
Action Taken
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.