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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 June 16, 2003
Date Posted August 07, 2003
Recall Status1 Terminated 3 on April 23, 2004
Recall Number Z-1090-03
Recall Event ID 26678
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Product Misys Laboratory System versions 5.3 up to 5.3.2 with Anatomic Pathology Module
Code Information Version 5.3 and up to 5.3.2 with Anatomic Pathology Module.
Recalling Firm/
Manufacturer		 Misys Healthcare Systems
4801 E Broadway Blvd
Tucson AZ 85711
For Additional Information Contact Barbara Brown
520-570-2000
Manufacturer Reason
for Recall		 Software anomaly allows patient reports to contain incomplete data used for diagnosis or treatment.
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce 315
Distribution Nationwide and to UK, Ireland, Canada, Bermuda, Saudi Arabia.
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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