Azurion 7 M12, M20 (2019-07-05)

Starting date:

July 5, 2019

Posting date:

July 19, 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-70447

Last updated: 2019-07-19

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  Reason
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  Affected products

Affected Products

1. Azurion 7 M12
2. Azurion 7 M20

Reason

When performing Cine runs, the Azurion's automatic exposure control software may set technique factors that result in radiation emissions too low to obtain useful diagnostic images.

This problem may occur after the following sequence of events:

1. Thickness of the patient is 30 cm or more.
2. A fluoro scan is performed.
3. A field of view (FOV) different than the largest FOV is selected.
4. A Cine run is performed.

The problem does not occur:

1. If the largest FOV is selected or
2. When performing fluoroscopy or test shot lock in (TSLI) runs.

Affected products