AZURION 7 M20 (2020-04-09)

Starting date:

April 9, 2020

Posting date:

May 1, 2020

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-72921

Last updated: 2020-05-01

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  Reason
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  Affected products

Affected Products

AZURION 7 M20

Reason

When a user acquires XperCT scan on an AZURION 2.0 System, enters the XperGuide guidance step and moves the L-arm away from the initial scan position before starting the live guidance, a warning message is displayed in the main screen directing the user to move the L-arm stand back to the initial XperCT scan position. Although the software generates this message, it does not prevent the use of live guidance if the L-arm stand is not repositioned. Using live guidance with a mispositioned L-arm can result in the display of an incorrect overlay and needle path.

Affected products