Recall Z-0670-2018— Medtronic Inc.

Class II FDA medical device recall by Medtronic Inc., initiated 2017-10-10, terminated 2021-03-26. FDA's recall record names no specific 510(k) clearance for this event. Product: 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 to upload glucose sensor data stored on a recording device, capture BG meter readings through manual entry or wired-upload, retrospectively calibrate sensor data, and provide retrospective reports of continuous glucose information. The reports generated by the CareLink iPro software are intended for use by healthcare professionals to assist with diabetes clinical assessment, patient education, and therapy optimization.. Reason: 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..

Recalling firm

Medtronic Inc.

Classification

Class II

Status

Terminated

Initiated

2017-10-10

Terminated

2021-03-26

Firm location

Northridge, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.