Terminated

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); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal (TV); Transrectal (TR); and Intraoperative (abdominal , PV neurological).

FDA Recall Z-2404-2008 · Posted 2008-09-22

Recalling FirmGE Healthcare

Recall StatusTerminated

Product CodeIYO

Date Initiated2008-04-01

Date Terminated2011-12-11

Product Quantity1637

Reason for Recall

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.

Firm 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 contact information.

Root Cause

Software design

Distribution Pattern

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, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LATVIA, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PARAGUAY, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, and VENEZUELA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061682GE VOLUSON E8 ULTRASOUND SYSTEMGeneral Electric Co. · 2006-07-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.