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Z-1250-2025 Class II Ongoing

Recalled by Medimaps Group — Plan-les-Ouates

FDA device recall Z-1250-2025 was initiated by Medimaps Group on February 3, 2025 and is designated Class II. Reason for recall: Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines. The recall status is ongoing. Affected quantity: 2036 units (724 US, 1312 OUS).

Recall Details

Product Type: Devices
Report Date: March 12, 2025
Initiation Date: February 3, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2036 units (724 US, 1312 OUS)

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.

Distribution Pattern

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

Code Information

UDI-DI: (1) B214OSTBSI3120, (2) B214OSTBSI3110, (3) B214OSTBSIV310, (4) B214OSTBSIV300.