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U.S. Department of Health and Human Services

Class 2 Device Recall Discovery Package for Hologic QDR Xray Bone Densitometer

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 Class 2 Device Recall Discovery Package for Hologic QDR Xray Bone Densitometersee related information
Date Initiated by FirmJune 13, 2024
Date PostedJuly 16, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2373-2024
Recall Event ID 94905
510(K)NumberK023398 
Product Classification Densitometer, bone - Product Code KGI
ProductHorizon 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
Code Information 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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FEI Number 3005496266
Recalling Firm/
Manufacturer		 Hologic Inc
600 Technology Dr
Newark DE 19702-2463
For Additional Information ContactSkeletal Health Customer Support
+1-877-3714372
Manufacturer Reason
for Recall		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 Determined
Cause 2		Under Investigation by firm
Action***August 16, 2024 UPDATE*** After further review of the install base for systems in scope of the Horizon recall, updates made to the consignee list. From the original list, 270 systems have been identified to be out of scope of this recall. Additionally, 44 systems were identified to be in scope of the recall that were not on the original consignee list. Customer notifications for the additional 44 in scope systems were distributed on 8/13/2024. RES Updated Serial numbers. Hologic issued URGENT: MEDICAL DEVICE CORRECTION FA-00247 Letter on 6/26/24. Letter states reason for recall, health risk and action to take: Recommendations: " Do NOT scan patients that have active implanted medical devices, including but not limited to neurostimulators, pacemakers, cardiac defibrillators, continuous glucose monitors, or other bio-wearable sensors. " Any operator who has an active implanted medical device should also refrain from operating the system at this time. " Do NOT scan patients that are currently being treated with an electronic medical device. " Extend this communication to all pertinent staff in interaction and/or use with the Horizon DXA System. " Until the correction is completed, this letter and the specific warning below supersedes information provided on the Horizon DXA labeling and IFU pertaining to electromagnetic compatibility and electromagnetic interference. Rectification activity by Hologic: We are urgently investigating the permanent rectification actions required, and we will be in contact promptly once this is defined. A service appointment will be scheduled for the remediation activity. As additional clarification regarding the continued safe use of your Horizon DXA system, please note the following: This notice pertains to electromagnetic emissions, not ionizing radiation. Electromagnetic emissions are emitted by all electronic devices, such as cell phones, lights, computers, TVs, medical devices, among others. Further, please note that elec
Quantity in Commerce2,642 units (1037 units US; 1605 units OUS)
DistributionWorldwide 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.
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
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