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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 November 22, 2002
Date Posted January 11, 2003
Recall Status1 Terminated 3 on June 23, 2003
Recall Number Z-0423-03
Recall Event ID 25212
Product Misys Laboratory versions 5.23 and 5.3
Code Information Versions 5.23 and 5.3
Recalling Firm/
Manufacturer		 Sunquest Information Systems
4801 E Broadway Blvd
Tucson AZ 85711
For Additional Information Contact Mark Ellis
520-570-2000
Manufacturer Reason
for Recall		 Software anomally.
FDA Determined
Cause 2		 Other
Action A recall notice along witn instructions for avoiding conditions that might cause the observed anomalous results was faxed to all customers 11/22/2002.
Quantity in Commerce 623
Distribution Nationwide and to the United Kingdom, Ireland, Canada, Denmark, Bermuda, Saudi Arabia, United Arab Emirates,
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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