Device product
Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.
Z-1786-2019
Product summary
- Event
- Event 82828
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 83 downloads
- Official record key
device-enforcement:Z-1786-2019
Official wording
Reason: Insulin dosing calculations were erroneously high.
Code information: Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10
Distribution pattern: Nationwide and Dubai
Derived failure modes
-
Unknown
Insulin dosing calculations were erroneously high.