Pristina Serena (SenoAxys) (2019-05-19)

Starting date:

May 19, 2019

Posting date:

May 31, 2019

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-70077

Last updated: 2019-05-31

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  Reason
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  Affected products

Affected Products

Pristina Serena (SenoAxys)

Reason

If the Senographe Pristina gantry is rotated and the biopsy positioner is attached, the angulation angle may unexpectedly change during a motorized angulation motion, due to insufficient brake performance. This issue could result in injury to the patient's breast.

Affected products