Reported Mar 12, 2025 · Ongoing
Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version:…
Medimaps Group
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medimaps Group · Fongit · Plan-les-Ouates · N/A
Is this the product you have?
- Brand NameTBS
- Osteo Product NameTBS
- iNsight Model/Catalog NumberTBS iNsight v3
- x / pnOS-TBSi
- Software Version
V3.x: (1) V3.1.2(2) V3.1.1(3) V3.1.0(4)V3.0.0
- Product DescriptionTBS iNsight is a class II Medical Device software that is installed on bone densitometers for analysis of bone microarchitecture
- and bone health management ComponentNo
- Lot codes and dates
- UDI-DI
(1) B214OSTBSI3120(2) B214OSTBSI3110(3) B214OSTBSIV310(4) B214OSTBSIV300
- UDI-DI
- Amount recalled
- 2036 units (724 US, 1312 OUS)
Where it was sold
Why it was recalled
Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Medimaps Group recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.