Health product recall

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

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

A. Azurion 7 M12

Lot or serial number

Not applicable.

Model or catalog number

722 078

Companies
Manufacturer

Philips Medical Systems Nederland B.V.

Veenpluis 4-6

Best

5684 PC

NETHERLANDS

B. Azurion 7 M20

Lot or serial number

Not applicable.

Model or catalog number

722 079

Companies
Manufacturer

Philips Medical Systems Nederland B.V.

Veenpluis 4-6

Best

5684 PC

NETHERLANDS