Recall Z-1951-2019 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare, LLC
Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
| Date | Jan 19, 2019 |
| Status | Open, Classified |
| 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 |
| FDA record | Open on fda.gov |