Recall Z-2404-2008 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
GE Healthcare
GE Voluson E8 Ultrasound System with software versions 6.0.0, 6.0.1,6.1.0, 6.2.0, 6.2.1, 6.2.2, 6.2,3, 7.0.0, and 7.01. Intended for use by a qualified physician for ultrasound evaluation of Fetal?OB; abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric);
| Date | Sep 22, 2008 (initiated Apr 1, 2008) |
| Status | Terminated |
| Reason | Inaccurate dimension measurements in M-Mode when pan-Zoom is activated in GE Voluson E8 Ultrasound Systems. Of particular concern are potential inaccuracies of fetal cardiac measurements that may impact patient safety. |
| Root cause | Software design |
| Action | Consignees were sent a GE "Urgent Medical device Correction" letter dated April 1, 22008. The letter was addressed to Healthcare Administrator/Risk Manger; Chief of Intensive Care and Director of Clinical Engineering. The letter described the safety issue; affected product details; safety instructions stating that use of the system may be continued and measurements may be made safely in M-Mode by using HD-Zoom rather than pan-Zoom; product correction stating that a GE Healthcare Rep will contact consignees in the future to schedule software updates to resolve the issue at no charge; and conta |
| Quantity | 1637 |
| Distribution | Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV,NY, OH, OK, OR, PA, RI, SC, SC, TN, TX, UT, VA, VT,WA, WI, WV, WY, and PUERTO RICO, and countries of ARGENTINA, AUSTRALIA, AUS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061682 | GE VOLUSON E8 ULTRASOUND SYSTEM General Electric Co., Jul 12, 2006 |