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

FDA device recall Z-0541-2010 · posted 2009-12-16 · Terminated

Recall details

Recalling firm

GE Medical Systems, LLC

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

Action taken

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

Status

Terminated

Product code

IYO

Quantity affected

715

Distribution

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 RE

Date initiated

2009-10-22

Date posted

2009-12-16

Date terminated

2011-12-17

Location

Waukesha, WI

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