Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI,…
Medical device recall Z-2373-2024. Published in FDA’s Enforcement Report on Jul 24, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 24, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 2,642 units (1037 units US; 1605 units OUS) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
2,642 units (1037 units US; 1605 units OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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:…
Every code shown here, 1,994 characters
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 306191M 306192M 306193M 306194M 306218M 306223M 306224M 306225M 306235M 306237M 306240M 306241M 306242M 306244M 306250M 306251M 306253M 306254M 306255M 306258M 306259M 306260M 306261M 306262M 306263M 306264M 306270M 306272M 306273M 306274M 306278M 306279M 306283M 306289M 306290M 306291M 306292M 306293M 306294M 306295M 306296M 306297M 306298M 306300M 306314M 306319M 306320M 306323M 306330M 306331M 306332M 306333M 306336M 306337M 306338M 306339M 306340M 306341M 306343M 306344M 306345M 306346M 306353M 306365M 306368M 306369M 306372M 306373M 306375M 306381M 306386M 306387M 306388M 306389M 306390M 306392M 306393M 306394M 306395M 306396M 306397M 306398M 306400M 306403M 306404M 306405M 306406M 306407M 306413M 306416M 306417M 306420M 306421M 306425M 306427M 306429M 306439M 306440M 306441M 306442M 306443M 306446M 306449M 306450M 306451M 306452M 306453M 306454M 306463M 306465M 306466M 306467M 306468M 306469M 306470M 306471M 306475M 306477M 306478M 306479M 306480M 306481M 306482M 306484M 306485M…
FDA’s list runs to 21,389 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 13, 2024.
- FDA classified it on Jul 16, 2024.
- FDA’s Enforcement Report published it on Jul 24, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Hologic Inc, of Newark, DE.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 21,389 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.