Medimaps Group recalls Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.…

Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-1250-2025
• FDA 510(k) clearance · K152299The device's official FDA premarket clearance record
• FDA device classification · KGIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1170The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Medimaps GroupSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.