Recall Z-1250-2025 ยท KGI Densitometer, Bone
Medimaps Group
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
| Date | Feb 28, 2025 (initiated Feb 3, 2025) |
| Status | Open, Classified |
| Reason | Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines. |
| 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 pr |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152299 | TBS iNsight Medimaps Group SA, Apr 29, 2016 |