Medtronic Inc. recalls The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile dev

Recalled September 23, 2020 · FDA recall Z-2980-2020 · Medtronic

Hazard

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. · FDA Class II

Units

3,588 users

Sold at

International distribution including in the countries of EMEA - Austria, Belgium, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Kuwait, Latvia, Luxembourg, The Netherlands, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, and United Kingdom. Latin America- Chile, Colombia and Mexico Asia Pacific (APAC) - Australia, India, Japan, The Republic of Korea, Malaysia, New Zealand, Russia Federation, Singapore, Thailand, and Vietnam. Asia - Hong Kong North America - Canada

Description

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.

Product

The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.

Manufacturer(s)

Medtronic Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →