Hologic Horizon QDR densitometer recalled for possible VGA cable issue
Hologic found that some Horizon W and Horizon WI bone densitometers made from December 2024 to January 2025 were shipped without the validated VGA cables. Some of these systems were installed with VGA cables that may not meet Hologic's applicable performance and safety standards. The notice covers 198 units and reports no injuries.
From the FDA notice · Read the official notice ↗ · All Hologic recalls
What to do
- Contact Hologic, Inc. to confirm whether the VGA cable on your system is the validated cable; the notice does not say how the cable issue will be corrected.
- Check whether your system's serial number appears in the notice's list for the Horizon W (UDI 15420045505834) or the Horizon WI (UDI 15420045505865).
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Horizon QDR X-Ray Bone Densitometer; Models: 1. Horizon W, 2. Horizon-WI;
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 198
- Illnesses reported
- None reported
- Manufactured in
- 250 Campus Dr, Marlborough, Massachusetts, United States
- Classification
- Class II
- Recall number
- Z-0423-2027
In the FDA's words
- Description
- Horizon QDR X-Ray Bone Densitometer; Models: 1. Horizon W, 2. Horizon-WI; 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. 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; Distribution: Worldwide 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. Affected quantity: 198
- Hazard
- 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.