Public recall detail

Horizon X-Ray Bone Densitometer (Dxa)

2024-06-21

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Recall Safety notice
Quick summary

Quick summary: Horizon X-Ray Bone Densitometer (Dxa). Date: 2024-06-21.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Horizon X-Ray Bone Densitometer (Dxa). Date: 2024-06-21.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandHologic, Inc.
ProductHorizon X-Ray Bone Densitometer (Dxa)
IssueMedical devices - Performance
Recall classType I
IdentificationRA-75719

Affected products

ProductHorizon X-Ray Bone Densitometer (Dxa)
LotMore than 10 numbers, contact manufacturer.
ModelHORIZON C HORIZON A HORIZON W
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHorizon X-Ray Bone Densitometer (Dxa)

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare Industry
CategoryHealth products - Medical devices - Radiology
CompaniesHologic, Inc. 36 Apple Ridge Road, Danbury, Connecticut, United States, 06810
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-75719
Background{}
CompaniesHologic, Inc. 36 Apple Ridge Road, Danbury, Connecticut, United States, 06810
AudiencesHealthcare Industry
Source updated2024-06-21

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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