Company: SCC Soft Computer
Date of Enforcement Report 10/8/2008
Class:ll
PRODUCT
SoftPath GUI Release Software Versions 3.17 and 4.1. Used in pathology laboratory for receiving accessing specimen reports, billing and management reports for surgical, GYN, NON-GYN and Autopsy cases, Recall # Z-2329-2008
REASON
Loss of text misrepresented individual tissue diagnosis on the final diagnosis print out from the HIS system software. The specimen heading “J” was removed and the diagnosis appeared under the specimen heading “I” as a result the specimen with the heading “I” had two diagnosis.
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL, software corrections were sent as of October 30, 2003 to clients. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
355 units
DISTRIBUTION
Nationwide and Canada
