SIGNA ARTIST (2021-08-30)

Starting date:

August 30, 2021

Posting date:

September 17, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-76439

Last updated:
2021-09-17

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  Reason
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  Affected products

Affected Products

SIGNA ARTIST

Reason

GE healthcare has recently become aware of an issue that impacts breast imaging when running the Sagittal vibrant application with asset. If the Soslabwrap factor is larger than the default value, some slices may be missing, which can lead to a gap of anatomy in the 3D volume images.

Affected products