Company:GE Healthcare LLC.
Date of Enforcement Report 10/31/12
Class ll:
PRODUCT
GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 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. Recall Number Z-0125-2013
REASON
GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. This issue may result in a potential miscalculation of size.
RECALLING FIRM/MANUFACTURER
GE Healthcare LLC., Waukesha , WI on 5/24/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
12
DISTRIBUTION
Nationwide and countries of TAIWAN, ITALY, CANADA, and BAHRAIN
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