Misys Laboratory System versions 5.3 up to 5.3.2 with Anatomic Pathology Module
FDA device recall Z-1090-03 · posted 2003-08-07 · Terminated
Recall details
- Recalling firm
- Misys Healthcare Systems
- Reason for recall
- Software anomaly allows patient reports to contain incomplete data used for diagnosis or treatment.
- Action taken
- The firm sent a fax of Product Safety Notice PSN-03-L28 to customers on June 16, 2003 which contained a procedural workaround. Once the corrective software is released a second notice will be made to affected customers. Proposed recall completion date is 9/15/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 315
- Distribution
- Nationwide and to UK, Ireland, Canada, Bermuda, Saudi Arabia.
- Date initiated
- 2003-06-16
- Date posted
- 2003-08-07
- Date terminated
- 2004-04-23
- Location
- Tucson, AZ
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