Company: Medtronic MiniMed
Date of Enforcement Report: 2/18/04
Class: III
PRODUCT
Medtronic MiniMed Model 7311 Version 5.0B Solutions Pumps and Meters Software. Recall #Z-0531-04.
REASON
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.
CODE
All software versions 5.0A and 5.0B.
RECALLING FIRM/MANUFACTURER
Medtronic MiniMed, Northridge, CA, by Product Performance Update labeling in new shipments, starting on January 28, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Undisclosed.
DISTRIBUTION
Nationwide.