Calculator/Data Processing Module for Clinical Use
This recall has been terminated (originally issued July 20, 2004).
- Company
- Misys Healthcare Systems
- Recall Initiated
- August 12, 2003
- Posted
- July 20, 2004
- Terminated
- March 15, 2004
- Recall Number
- Z-0007-04
- Quantity
- 479
- Firm Location
- Tucson, AZ
- Official Source
- View on FDA website ↗
Reason for Recall
Software defect. Clinical Laboratory results failing quality assurance were filed directly to a patient's chart without review.
Distribution
Nationwide, UK, Ireland, Canada, Denmark, United Arab Emirates & Bermuda
Lot / Code Info
Versions 5.2, 5.23, & 5.3
Root Cause
Other
Action Taken
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.
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