09
Dec
2023

FDA Recall: Software Application Missing Decimal Separator for Parameter Range Guidance

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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

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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