TBS iNsight bone density software calculation variability on Hologic machines
TBS iNsight medical device software may produce inconsistent calculation results when operating on Hologic Horizon bone densitometers, particularly when comparing fast array scans to standard array scans.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is FDA Class II device software with potential (not confirmed) calculation accuracy variability and no reported injuries or illnesses. Per the rubric, when the source explicitly states no illnesses/injuries and the hazard is theoretical, the score is at most 3.
Plain-English summary
TBS iNsight is medical device software installed on bone densitometers to analyze bone microarchitecture and support bone health management. The software, manufactured by Medimaps Group, is designed for use with Hologic Horizon bone densitometers.
The software may produce variable calculation results when operating on Hologic Horizon machines, particularly when comparing fast array scans to standard array scans. This potential variability in calculations could affect the consistency of diagnostic results obtained from the device. No injuries or illnesses have been reported.
Affected versions include TBS iNsight v3.x software (versions 3.0.0, 3.1.0, 3.1.1, and 3.1.2). The product has been distributed to healthcare facilities in the United States and internationally.
Healthcare facilities using affected systems should contact Medimaps Group for guidance regarding software updates or other remediation options.
The recalled product
- Product
- Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2, (2) V3.1.1, (3) V3.1.0, (4)V3.0.0 Product Description: TBS iNsight is a class II Medical Device software that is installed on bone…
- Manufacturer
- Medimaps Group
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 (4)
- UDI-DI: (1) B214OSTBSI3120
- (2) B214OSTBSI3110
- (3) B214OSTBSIV310
- (4) B214OSTBSIV300.
Distribution
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