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Medtronic Inc. recalls Medtronic SynchroMed, Model A10
Recalled December 20, 2023 · FDA recall Z-0522-2024 · Medtronic
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. · FDA Class II
Units
2543 units
Sold at
Foreign Distribution
Description
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.
Product
Medtronic SynchroMed, Model A10
Manufacturer(s)
Medtronic Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →