FDA-Device2023-12-20Class II
Medtronic SynchroMed, Model A10
Medtronic Inc.
Hazard
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.
Sold states
Foreign Distribution
Affected count
2543 units
Manufactured in
8200 Coral Sea St Ne, N/A, Mounds View, MN, United States
Products
Medtronic SynchroMed, Model A10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0522-2024Don't want to check this manually?
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