Back to RecallTracker
Health Canada Medical devices

Horizon X-Ray Bone Densitometer (Dxa)

Issued June 21, 2024
Issue
During standard safety design verification tests, Hologic has identified a non-conformance in Horizon DXA devices. The 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. Recall start date: June 14, 2024
Hazard description
Performance
Product
Product name
Horizon X-Ray Bone Densitometer (Dxa)
Reference
ID
RA-75719