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
Check against the official notice below — it lists the full affected range.
GE Healthcare has recalled certain CT imaging systems including the Revolution EVO, Optima CT660, Optima CT670, and Optima CT680 models due to a hazard involving damaged cables. The identified problem is that some of these systems may have a damaged cable that can expose 120 volts of alternating current (120VAC) to service engineers who work inside the gantry portion of the equipment. A total of 4,007 affected devices have been distributed worldwide, including throughout the United States and numerous countries internationally.
The specific affected systems are identified by model and serial numbers listed in the recall documentation. The recall record does not specify a remedy or recommended corrective action for consumers or healthcare facilities with affected equipment.
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): 5454001-260, CBCGG1600028HM (817261ULTRA); 5454001-240, 00000389996HM0 (83021861077017); 5454001-40, 00000074499YC5 (850210882); 5454001-40, 00000075588YC4 (850210905); 5454001-40, 00000069668YC2 (850210888); 5454001-40, 00000075080YC2 (850210904); 5454001-40, 00000071456YC8 (850210894); 5454001-40, 00000077687YC2 (850210910); 5454001-40, 00000073633YC0 (850210902); 5454001-40, 00000073638YC9 (850210900); 5454001-40, 40GAN1600013YC (850210908); 5454001-240, 00000424383HM8 (HU1113CT01); 5454001-240, 00000391751HM5 (DPN26338); 5454001-240, 00000387390HM8 (UE535A128); 5454001-240, 00000394185HM3 (NEV44709); 5454001-240, 00000394592HM0 (NEV44708); 5454001-240, 00000395002HM9 (NPV79344); 5454001-240, 00000415694HM9 (EP223318); 5454001-240, 00000414003HM4 (CS1346CT01); 5454001-240, 00000411639HM8 (CS1046CT01); 5454001-240, 00000385138HM3 (CS1335CT01); 5454001-240, 00000387391HM6 (H2021CT15); 5454001-240, 00000394590HM4 (H2049CT10); 5454001-240, 00000404914HM4 (H2016CT21); 5454001-240, 00000391756HM4 (H2017CT11); 5454001-240, 00000403534HM1 (HU1015CT03); 5454001-240, 00000411637HM2 (HU1158CT02); 5454001-240, 00000405579HM4 (RO1098CT02); 5454001-240, 00000405574HM5 (RO1303CT01); 5454001-40, 00000066732YC9 (RO1188CT01); 5454001-240, 00000420282HM6 (SK1042CT01); 5454001-240, 00000370111HM7 (MEX70100); 5454001-40, 00000063901YC3 (CS1085CT01); 5454001-40, 00000066209YC8 (RO1115CT03); 5454001-40, 00000061249YC9 (RU8891CT01); 5454001-240, 0000041862
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.