Horizon X-Ray Bone Densitometer (Dxa) — recall 75719
Health Canada — Medical Devices · Canada · 2024-06-21 · Type I
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Reported risk: 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
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