SCC Soft Computer 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
SCC Soft Computer
Lot Codes / Batch Numbers
Versions 3.17 and 4.1
Products Sold
Versions 3.17 and 4.1
SCC Soft Computer is recalling SoftPath GUI Release Software Versions 3.17 and 4.1. Used in pathology laboratory for receiving acc due to Loss of text misrepresented individual tissue diagnosis on the final diagnosis print out from the HIS system software. The specimen heading "J" was r. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026