SoftPath GUI Release Software Versions 3.17 and 4.1. Used in pathology laboratory for receiving accessing specimen repor
FDA device recall Z-2329-2008 · posted 2008-09-22 · Terminated
Recall details
- Recalling firm
- SCC Soft Computer
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 335
- Distribution
- Worldwide Distribution including USA and the country of Canada.
- Date initiated
- 2006-02-23
- Date posted
- 2008-09-22
- Date terminated
- 2008-11-20
- Location
- Clearwater, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.