Medimaps TBS iNsight Software Recalled for Incorrect FRAX Calculations
Medimaps Group is recalling TBS iNsight v.3.0.1 software because FRAX values are incorrect when specific spine scan conditions are met.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a software calculation error leading to incorrect data, which fits the criteria for a moderate severity recall involving low-risk issues or voluntary precautionary measures without reported harm.
Plain-English summary
Medimaps Group is recalling TBS iNsight Version v.3.0.1, a medical device software installed on bone densitometers for the analysis of bone microarchitecture and osteoporosis management. The recall involves 15 units in the United States, distributed nationwide in the states of Illinois, North Carolina, California, Delaware, New York, Maryland, Wisconsin, and Minnesota. The software is also distributed worldwide in numerous countries including France, Thailand, Canada, Italy, and the United Kingdom.
The recall is issued because the FRAX values adjusted for TBS are not correct when the FRAX feature is activated in TBS iNsight and TBS has been computed from a spine scan where some vertebrae were excluded. This defect may lead to inaccurate risk assessments for osteoporosis management.
Affected serial numbers include 14295, 300409, 70580, 200042, 500581, 70103, 70174, 80936, 100202, 201120, 84584, 83769, 100112, 210020, and 210440. Users should contact Medimaps Group for instructions on how to address the software defect.
The recalled product
- Product
- TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.
- Manufacturer
- Medimaps Group
- Category
- Medical Device — Software
- Hazard
- Affected units
- 15
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 (16)
- Version v.3.0.1
- Serial # 14295
- 300409
- 70580
- 200042
- 500581
- 70103
- 70174
- 80936
- 100202
- 201120
- 84584
- 83769
- 100112
- 210020
- 210440
Distribution
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