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Recall Observatory FDA recall evidence

Device product

Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804

Z-1104-2020

November 19, 2019

Class II

Product summary

Firm
Dexcom Inc
Event
Event 84436
Status
Terminated
Classification
Class II
Quantity
237888 users registered.
Official record key
device-enforcement:Z-1104-2020

Official wording

Reason: It was reported that the user's low alarm feature on the iOS application were not properly alerting users when the user has enabled the Alert Schedule feature more than 30 days after installing the iOS application.

Code information: Software Number: SW11677 Software Version: 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804

Distribution pattern: US Nation-wide OUS: Austria; Belgium; Canada; Czechia; Denmark; Finland; Germany; Great Britain; Hong Kong; Ireland; Italy; Luxembourg; Netherlands; Norway; South Africa; Spain; Sweden, and Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    It was reported that the user's low alarm feature on the iOS application were not properly alerting users when the user has enabled the Alert Schedule feature more than 30 days after installing the iOS application.