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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm January 31, 2003
Date Posted March 06, 2003
Recall Status1 Terminated 3 on May 07, 2004
Recall Number Z-0614-03
Recall Event ID 25556
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Product Misys Laboratory System Versions 5.2, 5.23 and 5.3
Code Information Versions 5.2, 5.23 and 5.3
Recalling Firm/
Manufacturer		 Misys Healthcare Systems
4801 E Broadway Blvd
Tucson AZ 85711
For Additional Information Contact Mark Ellis
520-733-6403
Manufacturer Reason
for Recall		 Software anomaly. Rejecting the selected Autofiling status may result in the change being accepted rather than rejected.
FDA Determined
Cause 2		 Other
Action Firm sent notice by FAX on 1/31/2003. A workaround provided should prevent the problem until a software fix is made available. Clients can expect a notice when this is made available.
Quantity in Commerce 542
Distribution Nationwide and to United Kingdom, Canada, Denmark, Ireland, Bermuda, Saudi Arabia, United Arab Emirates.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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