Recall Z-2463-2008 ยท JQP Calculator/Data Processing Module, For Clinical Use
SCC Soft Computer
Product is SoftPath ASCII Software Releases 1.2, 2.1, 2.2, and 2.3.
| Date | Sep 22, 2008 (initiated Feb 23, 2006) |
| Status | Terminated |
| Reason | In the creation of revised report and supplemental reports diagnosis, text was inserted from another case. |
| Root cause | Software design |
| Action | Consignees were notified of recall and provided with a software correction patch ICC number 3618. |
| Quantity | 201 |
| Distribution | Distributed to 106 consignees located throughout the United States and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.