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Recall Observatory FDA recall evidence

Device product

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

Z-2106-2020

May 20, 2019

Class II

Product summary

Firm
Medtronic Inc.
Event
Event 85091
Status
Ongoing
Classification
Class II
Quantity
23,978
Official record key
device-enforcement:Z-2106-2020

Official wording

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.

Code information: Model Number CSS7200 (Guardian Connect App: iOS); Catalog Numbers: MMT-7821 (Guardian Connect Transmitter - GST4C); UPN - 00763000186333. There are no assigned lot or serial numbers.

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.