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

Is my product affected?

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

• UPC 00763000255404

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

What happened

Medtronic Inc. has recalled the Guardian Connect App CSS7200 iOS for use with compatible mobile devices. Following the release of a new software version to the CareLink Personal website, the iOS app for this continuous glucose monitoring system stopped automatically uploading patient data to the website. The recall affects approximately 3,588 users and has been distributed internationally across EMEA countries including 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, and the United Arab Emirates.

The source document does not specify a remedy or recommended course of action for affected consumers.

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

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.

Details from the source

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. Distribution: 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 Quantity: 3,588 users Lot/code info: Product Number - CSS7200 UDI (GTIN.UPN) - 00763000255404

Source

Official record: FDA (Device enforcement) ↗

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

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