Recall Z-0151-04 ยท JQP Calculator/Data Processing Module, For Clinical Use
Misys Healthcare Systems
Misys Laboratory System, Versions 5.2, 5.23, 5.3 up to 5.3.2.
| Date | Jul 20, 2004 (initiated Jul 7, 2003) |
| Status | Terminated |
| Reason | Software defect causes orders to be lost under certain conditions of use. A typographical error at the Accept/Modfy/Reject prompt will cause the order not to be processed by the system. |
| Root cause | Other |
| Action | Product Safety Notice PSN-03-L32 was issued by fax to customers on July 7, 2003. It communcated a procedural workaround and that a follow-up notification was pending completion of a software engineering project to correct the defect. |
| Quantity | 473 |
| Distribution | Nationwide and to United Kingdom, Ireland, Denmark, Canada, Bermuda, Saudi Arabia, United Arab Emirates, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.