Recall Z-1240-03 ยท JQP Calculator/Data Processing Module, For Clinical Use
Misys Healthcare Systems
Calculator/ Data Processing Module for Clinical Use
| Date | Oct 15, 2003 (initiated Jul 23, 2003) |
| Status | Terminated |
| Reason | Software Defect. Data used in the diagnosis and or treatment of a patient's illness are missing from the patient result report. |
| Root cause | Other |
| Action | Notification to all affected customers was sent by fax on 07/23/03 under PSN-03-L35, with the problem description, effective workaround and estimated release of coding modifications to the software version impacted. |
| Quantity | 466 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.