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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 FirmApril 01, 2003
Date PostedJune 05, 2003
Recall Status1 Terminated 3 on April 21, 2004
Recall NumberZ-0920-03
Recall Event ID 26266
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
ProductMisys Commercial Laboratory version 2.x thru 3.4.1
Code Information Versions 2.x through 3.4.1
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		Urgent care STAT reports are not printing in a timely fashion.
FDA Determined
Cause 2		Other
ActionRecall notifications were sent to users on April 1, 2003 in Product Safety Notice PSN-03-L16 by facsimile.
Quantity in Commerce109
DistributionNationwide and to Canada.
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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