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Medimaps Group Recalls
2 recalls on record · November 16, 2016 to March 12, 2025 · Medical Devices
Recalls by year
16
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 12, 2025Medical DevicesFDA
Medimaps Group recalls Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version
Hazard: Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.
November 16, 2016Medical DevicesFDA
Medimaps Group recalls TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densit
Hazard: The FRAX adjusted for TBS values 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.