Z-0531-04

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

Name: Z-0531-04 Medtronic MiniMed Model 7311 Version 5.0B Solutions Pumps and Meters Software
Creator: Medtronic MiniMed
Published: 2004-01-28
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2004-01-28 / Terminated / root cause: software

FDA source

Medtronic MiniMed began a recall of Medtronic MiniMed Model 7311 Version 5.0B Solutions Pumps and Meters Software on 2004-01-28. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0531-04
Status: Terminated
Initiated: 2004-01-28
Posted: 2004-02-10
Terminated: 2005-01-18
Recalling firm: Medtronic, Inc.
Product: Medtronic MiniMed Model 7311 Version 5.0B Solutions Pumps and Meters Software.
Product code: LZG Pump, Infusion, Insulin
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.
Root cause tag: software
FDA root cause: Other
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.
Distribution: undisclosed, assumed to be nationwide.
Product codes and lots: All software versions 5.0A and 5.0B

Product code LZG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)