Dexcom Inc recalls Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up to corrected Version…

Recall date

November 19, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1104-2020

FDA classification

Class II

Brand / firm

Dexcom Inc

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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