CLASS II ONGOING Device recall · Reported 12 Mar 2025 · FDA Enforcement Report
TBS Osteo TBS iNsight recalled by Medimaps Group
Medimaps Group is recalling TBS Osteo TBS iNsight, distributed nationwide in the US. The recall was initiated on 3 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1250-2025
- FDA event ID
- 96233
- Recalling firm
- Medimaps Group, Plan-les-Ouates
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Feb 2025
- FDA classified
- 28 Feb 2025
- Reported
- 12 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 3 Feb 2025 | Recall initiated by company | |
| 28 Feb 2025 | Classified by FDA | +25 days |
| 12 Mar 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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 densitometers for analysis of bone microarchitecture and bone health management Component: No
Where it was distributed
Domestic: AL, AZ, CA, CO, DE, FL, IL, LA, MA, MD, MI, MN, MO, MS, NC, NM, NY, OH, PA, SC, TX, UT, WA. International: ALGERIA, ANDORRA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, CHILE, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, SOUTH KOREA, LEBANON, MALAYSIA, MEXICO, MONTENEGRO, MOROCCO, NEPAL, NETHERLANDS, NEW ZEALAND, NORWAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY
Nationwide AlabamaArizonaCaliforniaColoradoDelawareFloridaIllinoisLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiNorth CarolinaNew MexicoNew YorkOhioPennsylvaniaPuerto Rico
Questions about this recall
Is TBS Osteo TBS iNsight recalled?
Yes. Medimaps Group recalled TBS Osteo TBS iNsight on 3 Feb 2025. The recall is Class II and its status is Ongoing. Recall number Z-1250-2025.
Why was it recalled?
Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.
Which lots are affected?
UDI-DI: (1) B214OSTBSI3120, (2) B214OSTBSI3110, (3) B214OSTBSIV310, (4) B214OSTBSIV300.
Where was it sold?
Domestic: AL, AZ, CA, CO, DE, FL, IL, LA, MA, MD, MI, MN, MO, MS, NC, NM, NY, OH, PA, SC, TX, UT, WA. International: ALGERIA, ANDORRA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, CHILE, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, SOUTH KOREA, LEBANON, MALAYSIA, MEXICO, MONTENEGRO, MOROCCO, NEPAL, NETHERLANDS, NEW ZEALAND, NORWAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medimaps Group
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TBS iNsight recalled by Medimaps Group | Medimaps Group | Device Malfunction | Nationwide |
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