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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Hologic Inc: Horizon X-Ray Bone Densitometers Recalled for Electromagnetic Safety Standards

Agency Publication Date: July 16, 2024
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Summary

Hologic Inc. is recalling 2,642 units of Horizon X-Ray Bone Densitometer (DXA) systems, including models Horizon-A, W, WI, C, and CI, because they do not meet international safety standards for electromagnetic compatibility. These medical devices, used to measure bone density, exceeded limits for electrical emissions, which could potentially interfere with the performance of other nearby medical equipment. While 1,037 units were distributed in the United States, thousands more were sold globally between 2023 and 2024. Consumers and healthcare providers should contact the manufacturer to determine if their specific serial number is affected and to receive further instructions.

Risk

The system failed to meet technical safety standards for electromagnetic performance, meaning it could emit electrical signals that interfere with the essential performance of other critical medical electrical equipment in the same environment. This interference could lead to incorrect readings or failures in nearby life-supporting or monitoring devices.

What You Should Do

  1. Check your device for the model name and serial number. This recall affects Horizon models A, W, WI, C, CI, A-CN, W-CN, WI-CN, and CI-CN.
  2. Verify your serial number against the extensive list of 1,037 affected U.S. units, which include numbers such as 305588M, 305953M, 306000M through 308903M, and 1,605 international units listed in the recall notice.
  3. Identify products using the Unique Device Identifier (UDI) codes: Model A (15420045505384), Model C (15420045505698), Model CI (15420045505827), Model W (15420045505834), and Model WI (15420045505865).
  4. Contact your healthcare facility's biomedical engineering department or Hologic Inc. directly at their Newark, Delaware facility to discuss potential technical adjustments or system updates.
  5. Report any interference issues or malfunctions involving these densitometers to Hologic Inc. or your local distributor immediately.
  6. For further information or additional questions, contact the FDA medical device recall line at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer correction/firm-initiated notification

How to: Contact your healthcare provider or the manufacturer for further instructions and potential technical updates to ensure electromagnetic compliance.

Affected Products

Product: Horizon X-Ray Bone Densitometer (DXA) System
Model / REF:
Horizon-A
Horizon-W
Horizon-WI
Horizon-C
Horizon-CI
Horizon-A-CN
Horizon-W-CN
Horizon-WI-CN
Horizon-CI-CN
Lot Numbers:
UDI 15420045505384
UDI 15420045505698
UDI 15420045505827
UDI 15420045505834
UDI 15420045505865
Serial Numbers: 305588M through 308903M (US)
Serial Numbers: 306310M through 306655M (OUS)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94905
Status: Active
Manufacturer: Hologic Inc
Sold By: Hologic Inc authorized distributors; Direct manufacturer sales
Manufactured In: United States
Units Affected: 2,642 units (1037 units US; 1605 units OUS)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.