Recall Z-1090-03 ยท JQP Calculator/Data Processing Module, For Clinical Use
Misys Healthcare Systems
Misys Laboratory System versions 5.3 up to 5.3.2 with Anatomic Pathology Module
| Date | Aug 7, 2003 (initiated Jun 16, 2003) |
| Status | Terminated |
| Reason | Software anomaly allows patient reports to contain incomplete data used for diagnosis or treatment. |
| Root cause | Other |
| Action | The firm sent a fax of Product Safety Notice PSN-03-L28 to customers on June 16, 2003 which contained a procedural workaround. Once the corrective software is released a second notice will be made to affected customers. Proposed recall completion date is 9/15/2003. |
| Quantity | 315 |
| Distribution | Nationwide and to UK, Ireland, Canada, Bermuda, Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.