Health product recall

Horizon X-Ray Bone Densitometer (Dxa)

Brand(s)
Last updated

Summary

Product
Horizon X-Ray Bone Densitometer (Dxa)
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare
Industry

Affected products

Affected products

Lot or serial number

Model or catalogue number

Horizon X-Ray Bone Densitometer (Dxa)

More than 10 numbers, contact manufacturer.

HORIZON C
HORIZON A
HORIZON W

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Hologic, Inc.
36 Apple Ridge Road, Danbury, Connecticut, United States, 06810
Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type I
Identification number
RA-75719

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