Company: GE Healthcare Integrated IT Solutions
Date of Enforcement Report 5/7/2008
Class:ll
PRODUCT
GE Centricity PACS RA1000 Workstation; for diagnostic image analysis, Recall # Z-1104-2008
REASON
Report missing characters: Four special characters, when entered into the exam notes, are not transferred to the preview panel or hard copy printout (greater than [>], less than [<], quotation mark ["], and apostrophe [']). This may not be evident to the end user, as the symbols only appear when the Exam Note window is open.
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington, IL, by letters dated December 28, 2007. Firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
423 units nationwide; 134 units internationally
DISTRIBUTION
Nationwide and Internationally