Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Horizon

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Horizonsee related information
Date Initiated by FirmOctober 20, 2026
Date PostedNovember 12, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0423-2027
Recall Event ID 100116
510(K)NumberK023398 
Product Classification Densitometer, bone - Product Code KGI
ProductHorizon QDR X-Ray Bone Densitometer; Models: 1. Horizon W, 2. Horizon-WI;
Code Information 1. Model Horizon W; UDI:15420045505834; Serial Numbers: 308912M, 308911M, 308909M, 308908M, 308905M, 308899M, 308892M, 308890M, 308887M, 308925M, 308921M, 308918M, 308969M, 308968M, 308965M, 308964M, 308960M, 308956M, 308947M, 308945M, 308944M, 308942M, 308940M, 308939M, 308936M, 308934M, 308932M, 308928M, 309026M, 309017M, 309033M, 309029M, 309066M, 309045M, 309071M, 309048M, 309094M, 309109M, 309106M, 309104M, 309099M, 309146M, 309144M, 309136M, 309133M, 309126M, 309122M, 309117M, 309113M, 309184M, 309181M, 309177M, 309150M, 309704M, 309702M, 309700M, 309709M, 309707M, 309719M, 309715M, 309713M, 309741M, 309740M, 309738M, 309736M, 309735M, 309734M, 309733M, 309732M, 309731M, 309730M, 309729M, 309727M, 309726M, 309725M, 309724M, 309723M, 309722M, 309717M, 309711M, 308823M, 309743M, 309739M, 309751M, 309749M, 309747M, 309745M; 2. Model Horizon WI; UDI: 15420045505865; Serial Numbers: 308848M, 308823M, 308818M, 308866M, 308862M, 308858M, 308855M, 308906M, 308902M, 308889M, 308884M, 309003M, 309002M, 309001M, 308946M, 308943M, 308941M, 308938M, 308937M, 308933M, 309008M, 309007M, 309006M, 309005M, 309004M, 309027M, 309023M, 309041M, 309037M, 309035M, 309032M, 309030M, 309069M, 309064M, 309062M, 309043M, 309039M, 309082M, 309080M, 309078M, 309076M, 309072M, 309070M, 309084M, 309187M, 309180M, 309176M, 309197M, 309196M, 309194M, 309193M, 309191M, 309189M, 309244M, 309243M, 309241M, 309240M, 309236M, 309265M, 309263M, 309251M, 309282M, 309255M, 309303M, 309298M, 309296M, 309293M, 309315M, 309312M, 309309M, 309306M, 309329M, 309326M, 309320M, 309346M, 309343M, 309340M, 309338M, 309336M, 309335M, 309362M, 309357M, 309356M, 309354M, 309374M, 309370M, 309359M, 309385M, 309379M, 309675M, 309703M, 309701M, 309699M, 309708M, 309705M, 309718M, 309716M, 309728M, 309742M, 309737M, 309721M, 309744M, 309714M, 309712M, 309710M, 309752M, 309750M, 309748M, 309746M, 309754M, 309753M;
FEI Number 1000120743
Recalling Firm/
Manufacturer		 Hologic, Inc
250 Campus Dr
Marlborough MA 01752-3020
For Additional Information ContactSkeletal Health Customer Support
1-800-371-4372
Manufacturer Reason
for Recall		A nonconformance was identified for systems manufactured from December 2024 to January 2025 that were shipped without the validated VGA cables. Some installations were completed using VGA cables that may not meet Hologic s applicable performance and safety standards for this system.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn October 20, 2026 URGENT: MEDICAL DEVICE RECALL (Correction) letters were sent to customers. Actions to be taken: 1) Inform individuals within your organization who need to be aware of this action. 2) Be aware that a Hologic Field Service Representative will be contacting your site to inspect and remediate your Horizon system s cable connection. 3) Confirm receipt of this communication by completing the online Customer Response Form. Please note, a response is required and requested within five business days. Hologic has partnered with a third party, IQVIA, for tracking and customer follow-ups. They may contact you via phone or email if responses are not received. 4) Maintain awareness of this communication internally until all actions have been completed at your facility.
Quantity in Commerce198
DistributionWorldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Dominican Republic, France, Germany, Greece, India, Iran, Islamic Republic of, Israel, Italy, Japan, Korea, Republic of, Lebanon, Malaysia, Mexico, Morocco, Nepal, New Zealand, Pakistan, Peru, Philippines, Portugal, Romania, Saudi Arabia, Singapore, South Africa, Spain, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KGI
-
-