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
- Recall Initiated
- February 3, 2025
- Posted
- February 28, 2025
- Recall Number
- Z-1250-2025
- Quantity
- 2036 units (724 US, 1312 OUS)
Reason for Recall
Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.
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
Lot / Code Info
UDI-DI: (1) B214OSTBSI3120, (2) B214OSTBSI3110, (3) B214OSTBSIV310, (4) B214OSTBSIV300.
Root Cause
Software Design Change
Action Taken
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.