Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2463-2008

Product is SoftPath ASCII Software Releases 1.2, 2.1, 2.2, and 2.3

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

SCC Soft Computer began a recall of Product is SoftPath ASCII Software Releases 1.2, 2.1, 2.2, and 2.3 on . The reason FDA records is "In the creation of revised report and supplemental reports diagnosis, text was inserted from another case". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-2463-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
SCC Soft Computer
Product
Product is SoftPath ASCII Software Releases 1.2, 2.1, 2.2, and 2.3.
Product code
JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall
In the creation of revised report and supplemental reports diagnosis, text was inserted from another case.
Root cause tag
software
FDA root cause
Software design
Action
Consignees were notified of recall and provided with a software correction patch ICC number 3618.
Quantity in commerce
201
Distribution
Distributed to 106 consignees located throughout the United States and Canada.
Product codes and lots
Version 1.2, 2.1, 2.2 and 2.3