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Terminated

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

FDA Recall Z-0531-04 · Posted 2004-02-10

Recalling FirmMedtronic MiniMed
Recall StatusTerminated
Product CodeLZG
Date Initiated2004-01-28
Date Terminated2005-01-18

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.

Firm Action

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

Distribution Pattern

undisclosed, assumed to be nationwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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