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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84436

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
November 19, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Dexcom Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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
Recall number
Z-1104-2020
Initiated
November 19, 2019
Classification
Class II
Status
Terminated
Recalling firm
Dexcom Inc
Quantity
237888 users registered.

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.