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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmJanuary 28, 2004
Date PostedFebruary 10, 2004
Recall Status1 Terminated 3 on January 18, 2005
Recall NumberZ-0531-04
Recall Event ID 28214
Product Classification Pump, Infusion, Insulin - Product Code LZG
ProductMedtronic MiniMed Model 7311 Version 5.0B Solutions Pumps and Meters Software.
Code Information All software versions 5.0A and 5.0B
Recalling Firm/
Manufacturer		 Medtronic MiniMed
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information ContactMark J. Faillace
800-933-3322
Manufacturer Reason
for Recall		A minor software anomaly results in an error in the calculation of the average glucose range that appears on one of the reports available in the model 7311 software.
FDA Determined
Cause 2		Other
ActionFirm will send a Product Performance Update in all new shipments of the model 7311 version 5.0B software and it will be provided to all customers already receiving the version B software. When available, version 5.0c will be provided to customers with A or B software.
Distributionundisclosed, assumed to be nationwide.
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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