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
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