Recall Z-0541-2010 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
GE Medical Systems, LLC
GE Healthcare Voluson E6, GE Voluson E8, and GE Voluson E8 Expert Diagnostic Ultrasound Systems
| Date | Dec 16, 2009 (initiated Oct 22, 2009) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Software design |
| 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 Ultraso |
| Quantity | 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 REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, HUNGARY, INDIA, INDO |
| 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 |