Medimaps Group recalls TBS iNsight v3.x software versions (V3.0.0-V3.1.2) due to potential calculation variability when used with Hologic Horizon machines. Affected users should contact for remedy.
Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.
Medimaps Group recalls TBS iNsight v3.x software versions (V3.0.0 to V3.1.2) because they may produce inconsistent bone density calculations when used with Hologic Horizon machines. This could lead to inaccurate health assessments if the software is used for medical decisions.
The software may calculate bone density differently when used with Hologic Horizon machines compared to standard array scans. This variability could result in inaccurate bone health assessments if the software is used for medical decisions.
Users of TBS iNsight v3.x software versions (V3.0.0 to V3.1.2) on bone densitometers. Medical professionals who rely on these devices for bone health analysis are most at risk.
Check if your TBS iNsight software version is V3.0.0, V3.1.0, V3.1.1, or V3.1.2. The product is sold with specific UDI-DI codes: B214OSTBSI3120, B214OSTBSI3110, B214OSTBSIV310, or B214OSTBSIV300.
Verify your TBS iNsight software version is V3.0.0 to V3.1.2 by checking the device settings or documentation.
TBS iNsight software versions V3.0.0, V3.1.0, V3.1.1, and V3.1.2.
Check the software version on your device; affected versions are V3.0.0 to V3.1.2 with UDI-DI codes B214OSTBSI3120, B214OSTBSI3110, B214OSTBSIV310, or B214OSTBSIV300.
The recall record does not specify a remedy, so contact Medimaps Group for guidance.
We’ve drafted a message you can send TBS Osteo to request your refund or repair — edit it as you like.
Subject: Recall Z-1250-2025 — TBS Osteo TBS Osteo Hello, I own a TBS Osteo that is covered by recall Z-1250-2025 from TBS Osteo. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.