Horizon X-Ray Bone Densitometer (Dxa)
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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 |
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
| Hologic, Inc. |
| 36 Apple Ridge Road, Danbury, Connecticut, United States, 06810 |
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