Medtronic Inc.: Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.

Is my product affected?

Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.

• UPC 00643169693142

Check against the official notice below — it lists the full affected range.

What happened

Medtronic Inc. is recalling the Guardian Connect App CSS7200 used on iPhone, iPad, and iPod Touch devices. The application may unexpectedly close without notifying the user that it has stopped running or communicating with the transmitter. When this occurs, users will not receive alerts about blood sugar events, including dangerously low (hypoglycemic) or high (hyperglycemic) conditions.

The affected devices were distributed outside the United States across approximately 30 countries, including the United Kingdom, Canada, Australia, and most of Europe. Approximately 9,328 registered users are affected. The product recall record does not specify what remedy or corrective action consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

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. 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, Quantity: Approximately 9,328 registered users Lot/code info: UDI - (01)00643169693142(10)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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