FDA-Device2019-05-15Class II
Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
Medtronic Inc.
Hazard
The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the user not receiving alerts that could be associated with hypoglycemic or hyperglycemic events.
Sold states
Distribution was only made OUS. Countries involved are: Austria, United Arab Emirate, Australia, Belgium, Switzerland, Chile, Colombia, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Hungary, Ireland, Israel, Iceland, Italy, Republic of Korea, Luxembourg, Netherlands, Norway, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Turkey, and South Africa.
Affected count
Approximately 9,328 registered users
Manufactured in
18000 Devonshire St, N/A, Northridge, CA, United States
Products
Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1282-2019Don't want to check this manually?
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