Recall Z-2870-2018 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare Japan Corporation
GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold under the following product names: CT GOLDSEAL LIGHTSPEED ULTRA, CT OPTIMA 660, CT OPTIMA 660 M40 3.5 LONG BJG, CT OPTIMA 660 M40 GT1700, CT OPTIMA 660 M40 GT1700 BEIJI, CT OPTIMA 660 M40 GT1700 HINO, CT OPTIMA 6
| Date | Apr 27, 2018 |
| Status | Terminated |
| Reason | GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry. |
| Root cause | Employee error |
| Action | The firm, GE Healthcare, sent an " URGENT MEDICAL DEVICE CORRECTION" letter dated 4/27/2018 to its Customers on about 04/27/2018. The letter describes the product, problem and actions to be taken. The customers were Instructed to: download and provide the updated Service Manual to the organization that services the equipment on site and informed customers that GE Healthcare would be correcting all affected devices at no cost. Questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or the local Sales Representative. GE Healthcare expanded the recall to include a |
| Quantity | 4,007 devices total (products 1, 2, 3) |
| Distribution | Worldwide Distribution: US (Nationwide) distribution to states of: AK, AL, CA, CO, CT, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, RI, SC, SD, TN, TX, UT, WI, WV, WY; and countries of:: ALGERIA, ARGENTINA, ARMENIA, AUSTRALIA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131576 | OPTIMA CT660 Ge Medical Systems, LLC, Aug 30, 2013 |