FDA-Device2019-06-26Class II
Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.
Monarch Medical Technologies
Hazard
Insulin dosing calculations were erroneously high.
Sold states
Nationwide and Dubai
Affected count
83 downloads
Manufactured in
2137 South Blvd Ste 300, N/A, Charlotte, NC, United States
Products
Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1786-2019Don't want to check this manually?
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