Recall Z-0007-04 ยท JQP Calculator/Data Processing Module, For Clinical Use
Misys Healthcare Systems
Calculator/Data Processing Module for Clinical Use
| Date | Jul 20, 2004 (initiated Aug 12, 2003) |
| Status | Terminated |
| Reason | Software defect. Clinical Laboratory results failing quality assurance were filed directly to a patient's chart without review. |
| Root cause | Other |
| Action | Product Safety Notice, PSN-03-L37 was issued to all affected clients by facsmile. The notice provides product users with a description of the problem, an effective workaround, and the estimated release of coding modifications to the software version impacted. |
| Quantity | 479 |
| Distribution | Nationwide, UK, Ireland, Canada, Denmark, United Arab Emirates & Bermuda |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.