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Terminated

GE Healthcare Voluson E6, GE Voluson E8, and GE Voluson E8 Expert Diagnostic Ultrasound Systems

FDA Recall Z-0541-2010 · Posted 2009-12-16

Recalling FirmGE Medical Systems, LLC
Recall StatusTerminated
Product CodeIYO
Date Initiated2009-10-22
Date Terminated2011-12-17
Product Quantity715

Reason for Recall

GE Healthcare has recently become aware of an incorrect operating procedure associated with software versions 9.0.0, 9.0.1, and 9.0.2 of the Voluson E6 or Voluson E8 Diagnostic Ultrasound Systems that may impact patient safety. When using the combination of 2D-CRI and PW with a steered Doppler angle, the displayed velocity scale is incorrect. The consequence can be an underestimation of flow v

Firm Action

Consignees were sent on 10/23/09 a GE healthcare "Urgent Medical Device Correction" letter dated 10/22/09. The letter was addressed to Hospital Administration/Risk manger, Primary Physician and Biomedical Dept. Manger. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. Questions and concerns regarding this issue are directed to the local GE Healthcare service representative or to 1-800-437-1171. GE also plans to update all of the affected GE Voluson E6, GE Voluson E8, and GE Voluson E8 Expert Diagnostic Ultrasound Systems that were distributed.

Root Cause

Software design

Distribution Pattern

AL, AR, CA, CT, FL, GA, IL, KS, KY, LA ME, MD, MA, MI, MN,MS, MO, NE NJ, NY, NC, OH, OK PA, SC, TN,TX, VA,WI. AUSTRALIA, AUSTRIA , BELGIUM, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ITALY, JAMAICA, JAPAN, KOREA, KUWAIT, LITHUANIA, MALAYSIA. NETHERLANDS, NE ZEALAND, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, UNITED ARAB, EMIRATES, UNITED KINGDOM, MEXICO, 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.

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