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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84290

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

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Event summary

Timeline bucket
July 12, 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

Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 - Product Usage: A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments.

Z-0929-2020
Recall number
Z-0929-2020
Initiated
July 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
Dexcom Inc
Quantity
112,415 receivers

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It has been reported that use of the mobile receiver with software version SW10617 rev 4.0.1.048 have reported: 1. the receiver becoming stuck on initialization screen when powering on. This will cause patients not to be able to receive glucose values or alerts; 2. Reinitialization of the receiver without user interaction. If this occurs, the receiver will either reboot and operate normally or require the user to press the Select button on the receiver in order to resume normal operation. In this situation, the user is provided an audio and vibratory alert every 5 minutes. Until the select button is pressed, patients will not receive glucose values or alerts.

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 has been reported that use of the mobile receiver with software version SW10617 rev 4.0.1.048 have reported: 1. the receiver becoming stuck on initialization screen when powering on. This will cause patients not to be able to receive glucose values or alerts; 2. Reinitialization of the receiver without user interaction. If this occurs, the receiver will either reboot and operate normally or require the user to press the Select button on the receiver in order to resume normal operation. In this situation, the user is provided an audio and vibratory alert every 5 minutes. Until the select button is pressed, patients will not receive glucose values or alerts.

Code information

All serial numbers of the G5 Mobile Receivers with software version SW10617 and software revision 4.0.1.048 Receiver Part Number/Reciver Kit Number/GUDID registered GTINS/ Receiver Kit Type: Dexcom G5 Mobile Receiver, MT22179 (BLK) Rev 013 and Rev 014 Receiver (mg/dL), Black STK-GF-001/ 10386270000238 - Starter Kit STK-RF-001/20386270000235 - Retail Starter Kit STR-GF-001/30386270000232 - Replacement Receiver Kit STK-GF-IUO/NA - Investigational Use STK-MC-001/00386270000606 - Medicare Starter Kit Dexcom G5 Mobile Receiver, MT22719 (PNK) Rev 012 and 013, Receiver (mg/dL), Pink STK-GF-PNK/ 30386270000263 - Starter Kit STK-RF-PNK/10386270000269 - Retail Starter Kit STR-GF-PNK/20386270000266 - Replacement Receiver Kit Dexcom G5 Mobile Receiver, MT22719 (BLU) Rev 012 and 013, Receiver (mg/dL), Blue STK-GF-BLU/ 30386270000270 - Starter Kit STK-RF-BLU/10386270000276 - Retail Starter Kit STR-GF-BLU/20386270000273 - Replacement Receiver Kit

Distribution pattern

US Nationwide distribution.