URGENT: MEDICAL DEVICE CORRECTION FA-00247

As you may be aware, Hologic has identified a non-conformance in Horizon DXA devices pertaining to electromagnetic compatibility requirements. After conducting a risk assessment, Hologic identified potential risk to humans who have active, implanted medical devices. Additionally, there is potential risk of interference with the essential performance of other electronic medical devices in close proximity to the equipment.

The machines impacted have been identified as Horizon Bone Densitometry Systems manufactured from March 11, 2022, and later, as well as a small number of systems that have been serviced for motor replacement in the past 2 years – as follows:

Product Name: 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

UDIs Impacted: 15420045505384; 15420045505698; 15420045505827; 15420045505834; 15420045505865.

We have included the full Hologic Medical Device Correction for those who did not receive it directly. ISCD advises that all users follow the recommendations provided by the manufacturer in the notification. We are currently looking at recommendations for how to scan those patients who do have active, implanted devices. We will make updates as they are available on this page.

For additional support, please contact Hologic’s Technical Support at 1-877-371-4372 or skeletalhealth.support@hologic.com.

Page updated 7/15/2024