Recall Z-1786-2019 ยท NDC Calculator, Drug Dose
Monarch Medical Technologies
Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.
| Date | May 3, 2019 |
| Status | Open, Classified |
| Reason | Insulin dosing calculations were erroneously high. |
| Root cause | Software change control |
| Action | The firm notified the consignees by email beginning on 05/03/2019. The notice alerted the consignee of the problem and provided an educational brief and a tip card to provide to the staff to remind them to always use clinical judgement in following EndoTool IV dose recommendations. |
| Quantity | 83 downloads |
| Distribution | Nationwide and Dubai |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132547 | ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS) Monarch Medical Technologies, Apr 17, 2014 |