Calculator/ Data Processing Module for Clinical Use
FDA device recall Z-1240-03 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Misys Healthcare Systems
- Reason for recall
- Software Defect. Data used in the diagnosis and or treatment of a patient's illness are missing from the patient result report.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 466
- Distribution
- Nationwide
- Date initiated
- 2003-07-23
- Date posted
- 2003-10-15
- Date terminated
- 2004-04-23
- Location
- Tucson, AZ
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