Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0265-04

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

Medtronic, Inc. / initiated 2003-11-19 / Terminated / root cause: software

Medtronic MiniMed began a recall of Medtronic MiniMed Model 7311Version 5.0A Solutions Pumps and Meters Software on . The reason FDA records is "Accessory software fails to report certain reports following download of data from 712 pump". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-0265-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medtronic, Inc.
Product
Medtronic MiniMed Model 7311Version 5.0A Solutions Pumps and Meters Software
Product code
LZG Pump, Infusion, Insulin
Reason for recall
Accessory software fails to report certain reports following download of data from 712 pump.
Root cause tag
software
FDA root cause
Other
Action
Sales personnel will visit each center and install the software and leave a CD. Or, instructions will be FEDEXed with a CD.
Quantity in commerce
1020
Distribution
Nationwide, Canada, Europe, Middle East and Africa
Product codes and lots
version 5.0A