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Recall Observatory FDA recall evidence

Device product

Medtronic SynchroMed, Model A10

Z-0522-2024

July 13, 2020

Class II

Product summary

Firm
Medtronic Inc.
Event
Event 93401
Status
Completed
Classification
Class II
Quantity
2543 units
Official record key
device-enforcement:Z-0522-2024

Official wording

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.

Code information: GTIN 00643169771031, All serial numbers with software version 1.1.300.

Distribution pattern: Foreign Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.