Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
Reported: May 15, 2019 Initiated: July 4, 2018 #Z-1282-2019
Product Description
Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
Reason for Recall
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.
Details
- Recalling Firm
- Medtronic Inc.
- Units Affected
- Approximately 9,328 registered users
- Distribution
- 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.
- Location
- Northridge, CA
Frequently Asked Questions
What product was recalled? ▼
Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.. Recalled by Medtronic Inc.. Units affected: Approximately 9,328 registered users.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 15, 2019. Severity: Moderate. Recall number: Z-1282-2019.
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