Recall – Glucose monitoring system power management issue

Company: Medtronic Inc.
Date of Enforcement Report: 6/10/2020
Class II

PRODUCT

Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices.

Recall Number: Z-2106-2020

REASON

Customers using the firm’s continuous glucose monitoring system application on an iPhone, iPad or iPod Touch with ios software version 12, 12.1, or 12,2 are likely to experience a shortened transmitter battery life (approximately 4-5 days instead of the normal 7 days or more) after a full charge.

RECALLING FIRM/MANUFACTURER

Medtronic Inc. on 5/20/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

23,978

DISTRIBUTION

US Nationwide

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