Recall Z-1623-2015 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare
CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and whole body CT scanner utilizing a new solid state detector.
| Date | May 15, 2015 (initiated Apr 22, 2015) |
| Status | Terminated |
| Reason | GE Healthcare has become aware that 3 bolts that secure a power supply to the rotating side of the gantry were over-torqued on certain Lightspeed 16 CT scanner or PET/CT DST Scanner.. In the unlikely event that the component becomes loose on the CT gantry during operation, it could result in serious bodily injury if the component were expelled. There were no incidents or injuries reported as a res |
| Root cause | Process design |
| Action | Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 25461 dated April 22, 2015. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology/Cardiology, and Radiologists/Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The letter stated that customers can continue to use their device. If the error occurs, then stop using the system and call a service representative to bring the system back into proper operation. For questions con |
| Quantity | 4 USA |
| Distribution | Distributed to the states of MN, FL & TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013561 | LIGHTSPEED 4.0 CT SCANNER SYSTEM GE Medical Systems, Nov 8, 2001 |