Cl Il GE Healthcare Voluson

Company:GE Medical Systems, LLC
Date of Enforcement Report 1/13/2010
Class:ll

PRODUCT
GE Healthcare Voluson E6, GE Voluson E8, and GE Voluson E8 Expert Diagnostic Ultrasound Systems. Recall # Z-0541-2010

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 velocities in the range of 30-60%. This operating procedure is typically used for quantification of carotid stenosis. The degree of the stenosis may be inaccurately quantified which may result in a delay in treatment.

RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems, LLC, Waukesh, WI, by letters dated October 22, 2009.
Manufacturer: GE Medical Systems, Kretziechnik GmbH & Co OHG, Zipf, Austria. Firm initiated recall is ongoing..

VOLUME OF PRODUCT IN COMMERCE
715 units

DISTRIBUTION
Nationwide and Internationally.

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Partners located in the US (CA, FL, MA, MN) and Italy.