Hologic, Inc: Horizon Qdr X-ray Bone Densitometer; Models: 1. Horizon W, 2. Horizon-wi
- Recalling firm
- Hologic, Inc
- Product
- Horizon QDR X-Ray Bone Densitometer; Models: 1. Horizon W, 2. Horizon-WI;
- Reason
- A nonconformance was identified for systems manufactured from December 2024 to January 2025 that were shipped without the validated VGA cables. Some installations were completed using VGA cables that may not meet Hologic s applicable performance and safety standards for this system.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-10-20
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Dominican Republic, France, Germany, Greece, India, Iran, Islamic Republic of, Israel, Italy, Japan, Korea, Republic of, Lebanon, Malaysia, Mexico, Morocco,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/4ff3b870-5a80-46ef-aa5f-b07f58e58e9d