Z-2329-2008

SoftPath GUI Release Software Versions 3.17 and 4.1. Used in pathology laboratory for receiving accessing...

Name: Z-2329-2008 SoftPath GUI Release Software Versions 3.17 and 4.1. Used in pathology laboratory for receiving accessing...
Creator: SCC Soft Computer
Published: 2006-02-23
License: https://open.fda.gov/license/

SCC Soft Computer / initiated 2006-02-23 / Terminated / root cause: software

FDA source

SCC Soft Computer began a recall of SoftPath GUI Release Software Versions 3.17 and 4.1. Used in pathology laboratory for receiving accessing specimen reports, billing and management reports for... on 2006-02-23. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2329-2008
Status: Terminated
Initiated: 2006-02-23
Posted: 2008-09-22
Terminated: 2008-11-20
Recalling firm: SCC Soft Computer
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.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag: software
FDA root cause: Other
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.
Quantity in commerce: 335
Distribution: Worldwide Distribution including USA and the country of Canada.
Product codes and lots: Versions 3.17 and 4.1

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)