Brand Name: Dexcom G6 CGM App for iOS Software Number recall
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…
Why was Brand Name: Dexcom G6 CGM App for iOS Software Number 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software Number: SW11677 Software Version: 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804
- 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…
- Recalling firm
- Dexcom Inc
- Quantity
- 237888 users registered.
- Distribution
- 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.
- Recall date
- February 19, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)