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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMarch 27, 2003
Date PostedMay 09, 2003
Recall Status1 Terminated 3 on April 21, 2004
Recall NumberZ-0804-03
Recall Event ID 25996
ProductMisys Laboratory System versions 5.23 and 5.3
Code Information Versions 5.23 and 5.3
FEI Number 1000306472
Recalling Firm/
Manufacturer		 Misys Healthcare Systems
4801 E Broadway Blvd
Tucson AZ 85711
Manufacturer Reason
for Recall		Software anomaly.
FDA Determined
Cause 2		Other
ActionThe firm sent notification of the situation in Product Safety Notice PSN-03-L14 by fax on 3/27/2003. It communicated a workaround solution and informed of an impending code addition intended to be made available at a future date.
Quantity in Commerce463
DistributionNationwide and to 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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