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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 March 26, 2003
Date Posted May 08, 2003
Recall Status1 Terminated 3 on April 21, 2004
Recall Number Z-0791-03
Recall Event ID 25993
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Product Misys Laboratory System versions 5.23 and 5.3
Code Information Versions 5.23 and 5.3
Recalling Firm/
Misys Healthcare Systems
4801 E Broadway Blvd
Tucson AZ 85711
For Additional Information Contact Mark Ellis
Manufacturer Reason
for Recall
With SMART enabled, for an accession number with multiple tests, credits and additions, the system may delete and reorder resulted tests.
FDA Determined
Cause 2
Action The firm faxed notification on 3/26/2003 along with a response form and a temporary procedural workaround in Product Safety Notice PSN-03-L13.
Quantity in Commerce 463
Distribution Nationwide and to United Kingdom, Ireland, Canada, Denmark, 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.