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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. 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) and Italy.