The Recall Desk
SevereFDA (Devices)·Z-1786-2019·Announced 2019-06-26

Monarch EndoTool IV Software Recalled for High Insulin Dosing Calculations

Monarch Medical Technologies is recalling EndoTool IV software versions 1.8 through 1.10 because insulin dosing calculations were erroneously high.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves erroneously high insulin dosing calculations, which poses a significant risk of serious injury or harm to patients.

Plain-English summary

Monarch Medical Technologies is recalling EndoTool IV software, specifically versions 1.8, 1.8.5 and higher, 1.9, and 1.10. The recall was initiated because the software's insulin dosing calculations were erroneously high.

The affected software was distributed nationwide and in Dubai, with 83 downloads recorded. This software is used for medical calculations related to insulin dosing.

Users of the affected software versions should stop using the software for insulin dosing calculations and contact Monarch Medical Technologies for further instructions or a fix.

The recalled product

Product
Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.
Manufacturer
Monarch Medical Technologies
Category
Medical Device — Software
Hazard
Affected units
83

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Versions 1.8
  • Version 1.8.5 and higher
  • and Version 1.9 and Version 1.10

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Monarch Medical Technologies

See all →

Same hazard · medication error

See all →