Company:GE Healthcare Integrated IT Solution
Date of Enforcement Report:1/31/2007
Class:ll
PRODUCT
GE Centricity PACS RA 1000 Workstation; for diagnostic image analysis; Software versions 2.1.XX. and 3.0.XX. used in combination with the GE Senographe 2000D, Senographe DS or Senographe Essential, Recall # Z-0373-2007
REASON
The Centricity PACS RA1000 Workstation Software may manifest certain mammography image display problems only if the images were acquired through GE Senographe versions 2000D, DS or Essential.
CODE
Versions 2.1.X.X. and 3.0.X.X.
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington, IL, by letter dated January 12, 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
198 units
DISTRIBUTION
Nationwide and Internationally
