Recall – Software error leads to RRT miscalculation

Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Date of Enforcement Report: 2/1/2019
Class II

PRODUCT

MEDTRONIC CARELINK 2090 programmer

Recall Number: Z-0795-2019

REASON

There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its Recommended Replacement Time (RRT).

RECALLING FIRM/MANUFACTURER

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN on 1/17/2019. Voluntary: Firm Initiated, recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
33,007 units

DISTRIBUTION
U.S. Nationwide and International

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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