Z-1250-2025Class II

Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software...

Name: Z-1250-2025 Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software...
Creator: Medimaps Group
Published: 2025-02-03
License: https://open.fda.gov/license/

Medimaps Group SA / initiated 2025-02-03 / Open, Classified / root cause: software

FDA source

Medimaps Group began a recall of 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)... on 2025-02-03. FDA classified it as Class II and gives the reason as "Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1250-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-03
Posted: 2025-02-28
Recalling firm: Medimaps Group SA
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 densitometers for analysis of bone microarchitecture and bone health management Component: No
Product code: KGI Densitometer, Bone
Reason for recall: Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.
Root cause tag: software
FDA root cause: Software Design Change
Action: On February 5, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken by the user: Follow patient management recommendations. This notice needs to be passed on all organisation where the potentially affected devices have been transferred: the DXA manufacturer (Hologic), direct customers, distributors and field partners. Awareness on this notice and resulting action will be maintained through customer communications for an appropriate period of time until the end of the FSCA to ensure effectiveness of the corrective action. Customers are requested to report problem-related incidents to the manufacturer, distributor or local representative, and the national Competent Authority if appropriate, as this provides important feedback.* Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Action Being Taken by the Manufacturer: Software upgrade Medimaps will issue a maintenance release of the software by the end of February in the worst case and deploy it progressively in the field. The exact plan will be further communicated to customers. The associated FSCA for strongly recommended software update should be completed in 6 months starting from the release of the update version at the end of February 2025.
Quantity in commerce: 2036 units (724 US, 1312 OUS)
Distribution: 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
Product codes and lots: UDI-DI: (1) B214OSTBSI3120, (2) B214OSTBSI3110, (3) B214OSTBSIV310, (4) B214OSTBSIV300.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1250-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1250-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-02-28

Product code KGI

K152299Class IITBS iNsightMedimaps Group SA / cleared 2016-04-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)