Company:GE Healthcare LLC.
Date of Enforcement Report 6/9/2010
Class:ll
PRODUCT
GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis. Recall # Z-1747-2010
REASON
GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. When using the Print Image or Print Screen feature on SenoAdvantage 2.2, the Scale factor annotation printed on hard copy images is inaccurate. Secondary Capture (SCPT) images displayed on the screen and Secondary Capture hard copy images may also contain the inaccurate Scale factor annotation. This issue may result in a potential miscalculation of size.
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letter dated February 8, 2010.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
73 units
DISTRIBUTION
CA, FL, GA, MD, NJ, NM, NY, NC, OK, TX. and Internationally
