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.
FDA Recall Z-2329-2008 · Posted 2008-09-22
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Recalling FirmSCC Soft Computer
Recall StatusTerminated
Product CodeJQP
Date Initiated2006-02-23
Date Terminated2008-11-20
Product Quantity335
Reason for Recall
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.
Firm Action
Software corrections were sent as of 10/30/2003 for clients to upgrade to, the correction software patch is in versions 3.17.5.16, 3.17.6.10, 3.17.7.3 and 4.1.1.0. The firm did not inform the non-affected consignees of the failure because the firm concluded that the associated risk was low.
Root Cause
Other
Distribution Pattern
Worldwide Distribution including USA and the country of Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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