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
Being Agile & Yet Compliant (Public)
Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!
3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.
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Next public offerings:
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TBD
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2-days onsite with group exercises, quizzes, examples, Q&A.
Instructor: Dr Peter Rech, 2nd instructor (optional)
Next public offering: TBD
