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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