Z-0670-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 28, 2018
- Initiation Date
- October 10, 2017
- Termination Date
- March 26, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 488 uploads
Product Description
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 for Recall
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.
Distribution Pattern
Worldwide Distribution - US Distribution
Code Information
Version 1.12