Recall Z-1589-2016 ยท JAK System, X-Ray, Tomography, Computed
GE Medical Systems, LLC
GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications
| Date | Apr 29, 2016 (initiated Apr 20, 2016) |
| Status | Terminated |
| Reason | An out of tolerance torque tool was used on three joints during the manufacturing process. If the X-ray Tube becomes loose on the CT gantry during operation, this could result in beam tracking errors, potential scan aborts and/or a possible image artifact. There is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail. |
| Root cause | Process control |
| Action | GE Healthcare Systems sent an Urgent Medical Device Correction letter dated April 20, 2016, to all affected consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. |
| Quantity | 26 (US = 4;OUS = 22) |
| Distribution | Worldwide Distribution - US including FL, GA, NC, and TX and Internationally to AUSTRALIA, CANADA, CHINA, FRANCE, GERMANY, ITALY, JAPAN, REPUBLIC OF KOREA, NORWAY, PERU, SWEDEN UNITED ARAB EMIRATES, UNITED KINGDOM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133705 | REVOLUTION CT Ge Medical Systems, LLC, Apr 11, 2014 |