Atlas FDA

Medtronic MiniMed Model 7311 Version 5.0B Solutions Pumps and Meters Software.

FDA device recall Z-0531-04 · posted 2004-02-10 · Terminated

Recall details

Recalling firm
Medtronic MiniMed
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.
Action taken
Firm 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.
Root cause
Other
Status
Terminated
Product code
LZG
Distribution
undisclosed, assumed to be nationwide.
Date initiated
2004-01-28
Date posted
2004-02-10
Date terminated
2005-01-18
Location
Northridge, CA

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