Recall Z-2373-2024 ยท KGI Densitometer, Bone
Hologic Inc
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
| Date | Jul 16, 2024 (initiated Jun 13, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | 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 r |
| Quantity | 2,642 units (1037 units US; 1605 units OUS) |
| 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 Kin |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023398 | HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY Hologic, Inc., Nov 8, 2002 |