# FDA recall Z-2373-2024

> **Hologic Inc** · Class II · device recall initiated 2024-06-13.

## Product

Horizon X-Ray Bone Densitometer (DXA)    Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, Horizon-W-CN, Horizon-WI-CN, Horizon-CI-CN

## Reason for recall

Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essential performance of medical electrical equipment, where the result from the Horizon DXA System exceeded the limit for acceptability.

## Distribution

Worldwide distribution - US Nationwide and the countries of India, Australia, Spain, Estonia, Germany, Italy, Canada, Thailand, Dominican Republic, Portugal, Islas Canarias,  Andorra, Switzerland, Taiwan, Austria, Korea, Republic of Philippines, Kuwait, Slovakia,  China, Belgium, Ireland, United Kingdom, Malaysia, Palestinian Territory, Occupied, Peru, Singapore, Qatar, Algeria, Pakistan, New Zealand, Croatia, Brazil, Bangladesh,  Saudi Arabia, Venezuela, Israel, Lebanon, Nepal, Romania, Greece, Hong Kong, Morocco,  Indonesia, Cyprus, Jordan, France, Mexico, Colombia, Iran, Islamic, Republic of Chile,  Turkey, Uruguay, Viet Nam, Serbia, Poland, Japan, Malta, Netherlands, South Africa.

## Key facts

- **Recall number:** Z-2373-2024
- **Recalling firm:** Hologic Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-13
- **Report date:** 2024-07-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newark, DE, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2373-2024

## Citation

> AI Analytics. FDA recall Z-2373-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2373-2024. Source: US FDA. Licensed CC0.

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