Recall Z-1250-2025— Medimaps Group
Class II · Ongoing
Class II FDA medical device recall by Medimaps Group, initiated 2025-02-03. It names one FDA 510(k) clearance: K152299. 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. Reason: Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines..
- Recalling firm
- Medimaps Group
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-02-03
- Firm location
- Plan-les-Ouates, Switzerland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.
Data sourced from openFDA. This site is unofficial and independent of the FDA.