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

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