Calculator/ Data Processing Module for Clinical Use
This recall has been terminated (originally issued October 15, 2003).
- Company
- Misys Healthcare Systems
- Recall Initiated
- July 23, 2003
- Posted
- October 15, 2003
- Terminated
- April 23, 2004
- Recall Number
- Z-1240-03
- Quantity
- 466
- Firm Location
- Tucson, AZ
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide
Lot / Code Info
Verison 5.3 through 5.3.2
Root Cause
Other
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.
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