Hologic recalls Horizon X-Ray Bone Densitometer (DXA) models Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN due to electromagnetic compatibility issues with international medical standards. Affected units have serial numbers listed in the recall notice.
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.
Hologic is recalling specific models of their Horizon X-Ray Bone Densitometer (DXA) systems because they failed electromagnetic compatibility tests. This means the equipment might not work safely with medical standards, but the risk is not described as causing injury or death. Affected units have specific serial numbers listed in the recall notice.
The equipment failed electromagnetic compatibility testing according to international medical standards (IEC 60601-1-2). This means the device might not function properly with medical electrical systems, but the recall does not indicate a risk of injury or death.
Healthcare providers and medical facilities that own or use the recalled Horizon X-Ray Bone Densitometer models. The risk is low as the issue relates to electromagnetic compatibility, not immediate safety hazards.
Check if your device has a serial number listed in the provided recall notice (e.g., 305588M, 305953M, etc.). The affected models are Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, and Horizon-A-CN.
Look for the serial number on your device to see if it matches the list of affected units provided in the recall notice.
The affected models are Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, and Horizon-A-CN.
Check the serial number on your device against the list of affected serial numbers provided in the recall notice.
The recall states the device failed electromagnetic compatibility tests but does not indicate a risk of injury or death.
We’ve drafted a message you can send Hologic to request your refund or repair — edit it as you like.
Subject: Recall Z-2373-2024 — Hologic Hologic Hello, I own a Hologic that is covered by recall Z-2373-2024 from Hologic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
