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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 FirmJanuary 31, 2003
Date PostedMarch 06, 2003
Recall Status1 Terminated 3 on May 07, 2004
Recall NumberZ-0614-03
Recall Event ID 25556
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
ProductMisys Laboratory System Versions 5.2, 5.23 and 5.3
Code Information Versions 5.2, 5.23 and 5.3
Recalling Firm/
Manufacturer
Misys Healthcare Systems
4801 E Broadway Blvd
Tucson AZ 85711
For Additional Information ContactMark Ellis
520-733-6403
Manufacturer Reason
for Recall
Software anomaly. Rejecting the selected Autofiling status may result in the change being accepted rather than rejected.
FDA Determined
Cause 2
Other
ActionFirm sent notice by FAX on 1/31/2003. A workaround provided should prevent the problem until a software fix is made available. Clients can expect a notice when this is made available.
Quantity in Commerce542
DistributionNationwide and to United Kingdom, Canada, Denmark, Ireland, Bermuda, Saudi Arabia, United Arab Emirates.
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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