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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Instructors:  Brian Pate, John F. Murray, Jr
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Dates:  February 4-6, 2020
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QSS Software Validation
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Location: Boston, MA, USA
Dates:  June 2-4, 2020
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Corporate Office

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