Company: Medtronic Inc.
Date of Enforcement Report: 12/09/2023
Class II
PRODUCT
Medtronic SynchroMed, Model A10
Recall Number:
Z-0522-2024
REASON:
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.
RECALLING FIRM/MANUFACTURER:
Medtronic Inc.
VOLUME OF PRODUCT IN COMMERCE:
2543 units
DISTRIBUTION:
Foreign Distribution
