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American
Journal of Roentgenology ▼ American College of
Radiology▼
Radiology
Recalls
June 10, 2010
PRODUCT -
Mammography
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 CODE
Serial Numbers: 000000A9316002 000000A9316008
000000F9314002 000000F9314013 000000Q9309007
000000Q9309012 000000Q9309013 000000Q9309015
000000W9321002 000000W9321004 000000A9316004
000000A9316014 000000A9316015 000000A9345002
000000A9345003 000000A9345007 000000A9345009
000000A9345019 000000A9345020 000000F9314005
000000F9314010 000000F9314014 000000Q9309002
000000Q9309003 000000Q9309006 000000W9321003
000000P9300003 000000A9316012 000000P9300002
000000F9314011 000000W9321001 000000W9321007
000000W9321008 000000W9321010 000000W9321006
000000A9316006 000000A9316003 000000A9316005
000000P9300001 000000Q9309010 000000Q9309014
000000A9345015 000000Q9309005 000000A9316011
000000A9345012 000000A9345013 000000A9345014
000000A9345016 000000A9345018 000000F9314004
000000Q9309001 00000D10011003 00000D10011006
000000A9316001 000000F9314008 000000F9314012
000000P9300004 000000W9321009 000000A9316010
000000F9314007 000000W9321005 000000A9316007
000000A9316009 000000F9314015 000000F9314006
000000Q9356005 00000ZA9260001 000000Q9309008
000000A9345001 000000A9345017 000000F9314001
000000Q9309004 000000Q9356001 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. 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. VOLUME OF PRODUCT
IN COMMERCE
73 devices DISTRIBUTION
CA, FL, GA, MD, NJ, NM, NY, NC, OK, TX. and
Internationally
