Recall – Insulin pump remote accessories security vulnerability, CL I

Company: Medtronic Inc.
Date of Enforcement Report: 11/13/2019
Class I

PRODUCT

Minimed Model 500 Remote Control for use with the MiniMed 508 Insulin Pump, model number MMT-500RU.

  • Recall Number: Z-0177-2020

REASON

There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.

RECALLING FIRM/MANUFACTURER

Medtronic Inc. on 8/7/2018. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

17 units

DISTRIBUTION

Nationwide and International

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.