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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