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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 FirmMay 10, 2005
Date PostedJune 28, 2005
Recall Status1 Terminated 3 on August 30, 2005
Recall NumberZ-0939-05
Recall Event ID 32231
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
ProductMysis Laboratory version 6.1
Code Information Version 6.1
FEI Number 1000306472
Recalling Firm/
Manufacturer		 Misys Healthcare Systems
4801 E Broadway Blvd
Tucson AZ 85711-3609
For Additional Information ContactTom Goelz
520-570-2408
Manufacturer Reason
for Recall		When a previously reported microbiology organism result is deleted on a selected patient, reported susceptibilities will not stay with associated organisms and one or more suceptibilities on the culture will be deleted.
FDA Determined
Cause 2		Other
ActionFirm sent Product Safety Notice PSN 05-02 on May 10, 2005 which also provides a procedural work-around and an invitation to obtain a service pack to correct the software flaw.
Quantity in Commerce21
DistributionNationwide and United Kingdom and Denmark
Total Product Life CycleTPLC 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.
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