Horizon Bone Densitometer Devices Recalled for Electromagnetic Compatibility Issues
Hologic Inc. is recalling 2,642 Horizon X-Ray Bone Densitometer units due to non-conformance with electromagnetic compatibility safety standards. The devices exceeded acceptable limits per international technical standard IEC 60601-1-2.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall. Electromagnetic compatibility non-conformance to safety standard IEC 60601-1-2 creates potential device malfunction risk. The source does not report adverse events. This meets the rubric criterion for risk-of-harm products without reported injury, warranting High (3) severity.
Plain-English summary
Hologic Inc. is recalling 2,642 units of the Horizon X-Ray Bone Densitometer (DXA), a medical device used for measuring bone mineral density. Affected models include Horizon-A, Horizon-W, Horizon-WI, Horizon-C, and Horizon-CI variants. Units were distributed worldwide, including to the United States and numerous countries.
The recall is due to non-conformance with electromagnetic compatibility safety requirements. Testing identified that certain units exceeded the acceptability limits specified in the international technical standard IEC 60601-1-2, which governs the safety and essential performance of medical electrical equipment. Electromagnetic compatibility issues could potentially affect device performance or safety.
Healthcare facilities with affected serial numbers listed in the FDA recall should contact Hologic Inc. for further information and remediation instructions. Users should verify their device's serial number against the official recall notice and follow the manufacturer's recommendations.
The recalled product
- 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
- Manufacturer
- Hologic Inc
- Hazard
- electromagnetic-compatibility
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot Code: Model Horizon A
- UDI 15420045505384 Model Horizon C
- UDI 15420045505698 Model Horizon CI
- UDI 15420045505827 Model Horizon W
- UDI 15420045505834 Model Horizon WI
Distribution
Distributed nationwide across the United States.
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