Oct

2016

CareLink iPro Version 1.10 Cl II

Company: Medtronic Inc.
Date of Enforcement Report 10/5/2016
Class lI:

PRODUCT

CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports are created in PDF format, so they can easily be printed or stored electronically.
Recall Number Z-2898-2016

REASON
Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error.

RECALLING FIRM/MANUFACTURER
Medtronic Inc., Northridge, CA on 9/27/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
33 units

DISTRIBUTION
TN, MN, and WA

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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CareLink iPro Version 1.10 Cl II

Amy Sellers

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