Recall – Insulin dosing software error results in high calculations

Company: Monarch Medical Technologies
Date of Enforcement Report: 6/26/2019
Class II

PRODUCT

Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.

Recall Number: Z-1786-2019

REASON

Insulin dosing calculations were erroneously high.

RECALLING FIRM/MANUFACTURER

Monarch Medical Technologies on 5/3/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
83 downloads

DISTRIBUTION

US Nationwide and Dubai

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

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