PlainRecalls
FDA Devices Moderate Class II Completed

Medtronic SynchroMed, Model A10

Reported: December 20, 2023 Initiated: July 13, 2020 #Z-0522-2024

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.

Details

Recalling Firm
Medtronic Inc.
Units Affected
2543 units
Distribution
Foreign Distribution
Location
Mounds View, MN

Frequently Asked Questions

What product was recalled?
Medtronic SynchroMed, Model A10. Recalled by Medtronic Inc.. Units affected: 2543 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 20, 2023. Severity: Moderate. Recall number: Z-0522-2024.