FDA Medical Device Recalls (openFDA)
Medtronic MiniMed: Medtronic MiniMed Model 7311 Version 5.0B Solutions Pumps and Meters Software.
- Recall number
- Z-0531-04
- Recalling firm
- Medtronic MiniMed
- Product
- Medtronic MiniMed Model 7311 Version 5.0B Solutions Pumps and Meters Software.
- Status
- Terminated
- Initiated
- 2004-01-28
- Posted
- 2004-02-10
- Terminated
- 2005-01-18
- 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.
- 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.
- Quantity
- not on file
- Distribution
- undisclosed, assumed to be nationwide.
- Lot, serial or model codes
- All software versions 5.0A and 5.0B
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LZG
- Firm FEI
- 3003166194
- Firm city
- Northridge
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28