Z-0522-2024 Class II
Recall Details
- Product Type
- Devices
- Report Date
- December 20, 2023
- Initiation Date
- July 13, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2543 units
Product Description
Medtronic SynchroMed, Model A10
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 Pattern
Foreign Distribution
Code Information
GTIN 00643169771031, All serial numbers with software version 1.1.300.