Recall Z-2871-2018 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare Japan Corporation
GE Healthcare Optima CT660. Sold under the following product names: BEIJING OPTIMA CT660 PRO GT170, BEIJING OPTIMA CT660 PRO GT200, BEIJING OPTIMA CT660S PRO 32 S, CT GOLDSEAL, CT GOLDSEAL OPTIMA 660, CT GOLDSEAL OPTIMA 660 UT-BUC, CT OPTIMA 660 LNG HN P20, CT OPTIMA 660 MID HN P20, CT OPTIMA 660 PRO, CT OPTIMA 660 PRO LONG BJG P2., CT OPTIMA 660 PRO MID, CT OPTIMA 660 PRO MID HN P20, CT OPT
| 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
| K110227 | OPTIMA CT660 Ge Medical Systems, LLC, Jul 20, 2011 |