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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- 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.
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