GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.Sold under the following product names: BEIJING CT OPTIMA 540, BEIJING OPTIMA, BEIJING OPTIMA 540, BEIJING OPTIMA 540 ASIR, CT BEIJING OPTIMA 540, CT BEIJING OPTIMA
Check against the official notice below — it lists the full affected range.
GE Healthcare has recalled approximately 4,007 Optima CT540 computed tomography systems used for head, whole body, cardiac, and vascular X-ray imaging. The systems were distributed worldwide, including throughout the United States and numerous international countries. The recall was initiated because some CT systems may have a damaged cable that can expose 120 volts of alternating current to service engineers working inside the gantry, creating an electrical hazard.
The recall record does not specify a remedy or what affected consumers should do in response to this recall.
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): 5432539, 00000409871HM1 (IR1304CT02); 5432539, 00000406425HM9 (IR1563CT01); 5432539-2, Not Available (970GMCT1); 5432539-2, 343769HM6 (262434OPTCT1); 5432539, 383019HM7 (251809DWMCT); 5432539-2, 00000058405YC2 (928289CT); 5432539, 00000340698HM0 (TMCACT540); 5432539, 340698HM0 (AM16OG71165); 5432539, 377682HM0 (850314CT); 5432539, 00000333256HM6 (954916OPT16); 5432539, 00000350436HM2 (912466OCT); 5432539, 00000354310HM5 (770382ERCT); 5432539, 00000361670HM3 (919956CT); 5432539, 00000370798HM1 (704403KAN); 5432539, 00000358402HM6 (910642CT2); 5432539, 00000348412HM8 (SJRCT540); 5432539, Not Available (631367OPTMA); 5432539, 00000350435HM4 (803632CT16); 5432539, 00000377063HM3 (901516SCT2); 5432539, 00000353930HM1 (214276CT); 5432539, 00000358081HM8 (806592OPT); 5432539, 00000339268HM5 (817465PORT); 5432539, 397568HM7 (713MMRINWCT); 5432539, 00000348790HM7 (281949CF04); 5432539, 00000369111HM0 (713461MMCT); 5432539, 00000339269HM3 (571367OP540); 5432539, 00000359124HM5 (304526OPT540); 5432539, 00000341572HM6 (DZ1547CT01); 5432539, 00000394557HM3 (DZ1728CT01); 5432539-3, CBAQG1500007HM (DZ1865CT01); 5432539-3, 00000405602HM4 (83133304751); 5432539, 00000363481HM3 (BG4616CT02); 5432539, 00000343768HM8 (CM1059CT01); 5432539, 00000332406HM8 (416756BSCT); 5432539, 00000377064HM1 (M2521010); 5432539, 00000361671HM1 (D1215120); 5432539, 00000370797HM3 (M2800925); 5432539, 00000366018HM0 (M4490802); 5432539, 00000376544HM3 (83016600022314); 5432
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.