FDAOctober 10, 2017device

Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink iPro Therapy Management Software (model, MMT-7340) is intended to be used by a healthcare professional (HCP) with the iPro2 CGM System and provides upload support for the iPro2 Recorder. The CareLink iPro software is used ...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Due to a time conversion error, data uploaded from the iPro(TM)2 recorder to the CareLink iPro software using the new CareLink iPro Uploader feature may result in incorrect reports. This pertains only to reports generated between September 23, 2017 and September 27, 2017 that used the new CareLink iPro Uploader feature.

What to do

FDA enforcement status: Terminated

Brands named

medtronic

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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