Medtronic SynchroMed, Model A10
This recall has been completed (originally issued December 9, 2023).
- Company
- Medtronic Inc.
- Recall Initiated
- July 13, 2020
- Posted
- December 9, 2023
- Recall Number
- Z-0522-2024
- Quantity
- 2543 units
- Firm Location
- Mounds View, MN
- Official Source
- View on FDA website ↗
Reason for Recall
The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm.
Distribution
Foreign Distribution
Lot / Code Info
GTIN 00643169771031, All serial numbers with software version 1.1.300.
Root Cause
Software Design Change
Action Taken
Medtronic issued a SAFETY NOTIFICATION to its consignees on 07/13/2020 by letter. The notice explained the problem with the device and requested the software be upgraded to version 1.1.342.
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