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 PR
Check against the official notice below — it lists the full affected range.
GE Healthcare has recalled 4,007 CT systems sold under multiple product names including the Beijing Optima CT660 Pro GT170, GT200, and CT660S Pro 32S models. The systems were distributed worldwide to numerous U.S. states and countries. The recall was initiated because some units may have a damaged cable that can expose 120VAC electrical current to service engineers working inside the gantry.
The recall affects specific device serial numbers identified in the manufacturer's documentation. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.
Reason for recall: GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry. 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, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVIA, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, Quantity: 4,007 devices total (products 1, 2, 3) Lot/code info: Model Number, Serial Number (System ID): 5454001-220, 00000296364HM3 (910212220); 5454001-222, 00000316775HM6 (910216062); 5454001-222, 00000316560HM2 (GF1001CT02); 5454001-222, 00000312787HM5 (190163CT01); 5454001-200, 00000296053HM2 (M2842586); 5454001-222, 00000312788HM3 (M9024415); 5454001-220, 00000302025HM2 (M4189263); 5454001-222, 00000316776HM4 (600118CT01); 5454001-222, 00000305880HM7 (X140985807); 5454001-100, 427331CN4 (412357CT); 5454001-100, 424963CN7 (334826CT); 5454001-100, 373759GE0 (303LA660CT); 5454001-100, 428253CN9 (SHICT01432); 5454001-22, 51941YC3 (406434660); 5454001-100, 423901CN8 (201488OPT660); 5454001-100, 424944CN7 (516422CT660); 5454001-122, 00000431995CN0 (405473CT1); 5454001-222, 379369HM2 (864797OPT); 5454001-100, 424968CN6 (864482CT660); 5454001-122, 432338CN2 (703825OP660); 5454001-222, 325767HM2 (757388CT); 5454001-222, 00000316792HM1 (910212229); 5454001, 00000026201YC4 (83021000510515); 5454001, 00000026844YC1 (IL1000CT02); 5454001, 00000033401YC1 (A5634107); 5454001, 00000039355YC3 (850210791); 5454001, 00000029121YC1 (850210732); 5454001, 00000037278YC9 (850210764); 5454001-22, 00000058550YC5 (850210858); 5454001-22, 00000066104YC1 (850210865); 5454001-22, 00000066105YC8 (850210872); 5454001, 00000029510YC5 (850210727); 5454001, 00000029657YC4 (850210735); 5454001, 00000030118YC4 (850210745); 5454001, 00000030498YC0 (850210750); 5454001-22, 00000065974YC8 (850210876); 5454001, 00000030761YC1 (850210746); 5454001-22, 00000058893YC9 (85021
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.