Recall archive / FDA device enforcement

Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, ... — FDA record Z-2373-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jun 13, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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: 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.
Classification: Class II
Recalling firm: Hologic Inc
Quantity: 2,642 units (1037 units US; 1605 units OUS)
Agency-reported status: Ongoing
Source record identifier: Z-2373-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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; UDI15420045505865. ***UPDATE 8/16/24* US Serial Numbers: 305588M 305953M 305958M 305959M 305964M 305967M 305968M 305969M 305985M 305986M 305987M 305988M 305989M 305990M 305991M 305994M 305997M 305998M 305999M 306000M 306001M 306002M 306004M 306005M 306006M 306007M 306020M 306021M 306022M 306023M 306024M 306025M 306026M 306027M 306028M 306048M 306050M 306051M 306052M 306053M 306054M 306055M 306076M 306077M 306078M 306080M 306081M 306083M 306086M 306087M 306092M 306093M 306097M 306107M 306108M 306110M 306111M 306114M 306116M 306117M 306118M 306119M 306120M 306121M 306122M 306125M 306126M 306127M 306128M 306129M 306136M 306143M 306144M 306145M 306146M 306147M 306148M 306169M 306171M 306172M 306173M 306174M 306175M 306176M 306177M 306180M 306182M 306183M 306184M 306185M 306185M 306186M 306188M 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Details supplied by the agency

Lot, code or applicability

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; UDI15420045505865. *****UPDATE 8/16/24*** US Serial Numbers: 305588M 305953M 305958M 305959M 305964M 305967M 305968M 305969M 305985M 305986M 305987M 305988M 305989M 305990M 305991M 305994M 305997M 305998M 305999M 306000M 306001M 306002M 306004M 306005M 306006M 306007M 306020M 306021M 306022M 306023M 306024M 306025M 306026M 306027M 306028M 306048M 306050M 306051M 306052M 306053M 306054M 306055M 306076M 306077M 306078M 306080M 306081M 306083M 306086M 306087M 306092M 306093M 306097M 306107M 306108M 306110M 306111M 306114M 306116M 306117M 306118M 306119M 306120M 306121M 306122M 306125M 306126M 306127M 306128M 306129M 306136M 306143M 306144M 306145M 306146M 306147M 306148M 306169M 306171M 306172M 306173M 306174M 306175M 306176M 306177M 306180M 306182M 306183M 306184M 306185M 306185M 306186M 306188M 306189M 306190M 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307249M...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jul 24, 2024
Recall initiation date: Jun 13, 2024
Center classification date: Jul 16, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records