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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 October 24, 2002
Date Posted December 11, 2002
Recall Status1 Terminated 3 on February 26, 2013
Recall Number Z-0325-03
Recall Event ID 25077
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Product Misys Laboratory versions 5.2, 5.23, or 5.3 with ADT Interface to CoPathPlus.
Code Information Versions 5.2, 5.23 and 5.3 with ADT Interface to CoPathPlus.
Recalling Firm/
Sunquest Information Systems
4801 E Broadway Blvd
Tucson AZ 85711
For Additional Information Contact Mark Ellis
Manufacturer Reason
for Recall
Interfacing software systems have inconsistent character recognition characteristics.
FDA Determined
Cause 2
Action A recall notice was sent to hospitals on October 24, 2002. It communicated a temporary procedure to work around the problem. Also mentioned was the availabllity of a utility to detect and report suspected duplicate Medical Record Numbers.
Quantity in Commerce 190
Distribution Nationwide and to Denmark, Bermuda, United Kingdom, Saudi Arabia, Canada.
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.