| | Class 2 Device Recall Dexcom G7 Continuous Glucose Monitoring (CGM) System |  |
| Date Initiated by Firm | May 05, 2025 |
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| Date Posted | June 04, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1906-2025 |
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| Recall Event ID |
96684 |
| 510(K)Number | K231081 |
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| Product Classification |
Integrated Continuous Glucose Monitoring system, factory calibrated - Product Code QBJ
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| Product | Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system |
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| Code Information |
Software version 2.7.0/ UDI: 00386270001863 |
Recalling Firm/
Manufacturer |
Dexcom, Inc.
6340 Sequence Dr
San Diego CA 92121-4356
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| For Additional Information Contact | Chuck BOykin
858-200-0200 |
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Manufacturer Reason
for Recall | A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are not being updated
and that glucose alerts will not trigger, there is potential for the missed detection of a hyperglycemic or hypoglycemic event or a treatment decision made based off incorrect data. There is no impact to transmitter communication with concurrently connected displays. A
concurrently connected receiver, Apple Watch, and/or insulin pump will continue to receive EGVs directly from the transmitter when the app is in the problematic state. There is no impact to Automated Insulin Dosing (AID) therapy as the AID system continues to receive EGVs directly from the transmitter. |
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FDA Determined
Cause 2 | Software design |
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| Action | On May 05, 2025, Dexcom issued a "Urgent Warning" Recall notification to affected consignees via application update. Dexcom asked consignees to take the following actions:
1. Upgrading from app version 2.7 is mandatory and app version 2.7 is no longer available for use.
2. If you need assistance, contact Technical Support. Local Tech Support contact information is available at Dexcom.com
Please note that US customers should utilize one of the following options for support.
" Phone - 1-844-478-1600
" Call Back request Call Back Request Form
" Web Form - https://dexcom.custhelp.com/app/webform
" Live chat - https://dexcom.custhelp.com/app/chat/chat_avail
If you have any questions, call 858-200-0200 or email: Charles.boykin@dexcom.com. |
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| Quantity in Commerce | 61,355 users |
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| Distribution | Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: United Arab Emirates (AE), Austria (AT), Australia (AU), Belgium (BE), Bahrain (BH), Canada (CA), Switzerland (CH), Czech Republic (CZ), Germany (DE), Denmark (DK), Spain (ES), Finland (FI), France (FR), United Kingdom (GB), Hong Kong (HK), Ireland (IE), Israel (IL), Iceland (IS), Italy (IT), Jordan (JO), Korea, Repulic (KR), Kuwait (KW), Lebanon (LB), Lithuania (LT), Luxemburg (LU), Malta (MT), Netherlands (NL), Norway (NO), New Zealand (NZ), Oman (OM), Poland (PL), Portugal (PT), Qatar (QA), Saudi Arabia (SA), Sweden (SE), Slovenia (SI), Slovakia (SK), Turkey (TR) and South Africa (ZA).
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = QBJ
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