Health product recall

Azurion 7M12, M20, B12 & B20 (2019-11-04)

Starting date:
November 4, 2019
Posting date:
November 15, 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-71629



Last updated: 2019-11-19

Affected Products

  1. Azurion 7 M12
  2. Azurion 7 M20
  3. Azurion 7 B12
  4. Azurion 7 B20

Reason

Azurion systems have a smaller wire size requirement compared to previous systems released by Philips. This different requirement may not have been taken into account during room preparation before system installation. As a consequence, the current cable connection to the mains power may not meet the specification.

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


C. Azurion 7 B12

Lot or serial number

Not applicable.

Model or catalog number

722 067

Companies
Manufacturer

Philips Medical Systems Nederland B.V.

Veenpluis 4-6

Best

5684 PC

NETHERLANDS


D. Azurion 7 B20

Lot or serial number

Not applicable.

Model or catalog number

722 068

Companies
Manufacturer

Philips Medical Systems Nederland B.V.

Veenpluis 4-6

Best

5684 PC

NETHERLANDS