Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.
This recall is currently active, issued May 3, 2019. It was issued by Monarch Medical Technologies.
- Company
- Monarch Medical Technologies
- Recall Initiated
- May 3, 2019
- Recall Number
- Z-1786-2019
- Quantity
- 83 downloads
- Firm Location
- Charlotte, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Insulin dosing calculations were erroneously high.
Distribution
Nationwide and Dubai
Lot / Code Info
Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10
Root Cause
Software change control
Action Taken
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.
More recalls by Monarch Medical Technologies
EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
Oct 1, 2019