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GE Healthcare, LLC recalls GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. The device is a general purpose ultrasoun
Recalled August 7, 2013 · FDA recall Z-1833-2013 · GE Healthcare
Hazard
GE Healthcare has recently become aware that during use of the Voluson E6 or E8 systems, that an error message Out of Memory can be displayed which could cause the system to freeze. This is an intermittent behavior that also requires a certain workflow. This issue can be resolved by rebooting the system. · FDA Class II
Units
375
Sold at
Worldwide Distribution - US Distribution including the states AK, AZ, AR, CA, CO, CT, DE, FL, GA, IL, LA, MD, MI, MN, MO, NE, NV, NM, NY, NC, OH, OR, PA, SC, SD, TN,TX, VA, WA and WI., and the countries of ALGERIA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRIL, CANADA, CHINA, COLOMBIA, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, INDIA, IRAQ, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF MOLDOVA, NETHERLANDS, NORWAY, POLAND, ROMANIA, RUSSIAN FEDERATION, KINGDOM OF SAUDI ARABIA, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA.
Description
GE Healthcare has recently become aware that during use of the Voluson E6 or E8 systems, that an error message Out of Memory can be displayed which could cause the system to freeze. This is an intermittent behavior that also requires a certain workflow. This issue can be resolved by rebooting the system.
Product
GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: 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; Transrectal; and Intraoperative (abdominal, PV and neurological).
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →