Recall Z-2980-2020— Medtronic Inc.
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc., initiated 2020-07-15, terminated 2022-02-18. FDA's recall record names no specific 510(k) clearance for this event. Product: The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.. Reason: As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous Monitoring Glucose system stopped automatically uploading data to the website..
- Recalling firm
- Medtronic Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-15
- Terminated
- 2022-02-18
- Firm location
- Northridge, CA, United States
Product description
The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
Reason for recall
As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous Monitoring Glucose system stopped automatically uploading data to the website.
Data sourced from openFDA. This site is unofficial and independent of the FDA.