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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/
Misys Healthcare Systems
4801 E Broadway Blvd
Tucson AZ 85711
For Additional Information Contact Barbara Brown
Manufacturer Reason
for Recall
Software anomaly allows patient reports to contain incomplete data used for diagnosis or treatment.
FDA Determined
Cause 2
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.