Health product recall

AZURION 7 M20, B12 and B20 (2019-12-18)

Starting date:
December 18, 2019
Posting date:
January 6, 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-72025

Last updated: 2020-01-07

Affected Products

A. AZURION 7 M20
B. AZURION 7 B12
C. AZURION 7 B20

Reason

Due to a software defect, when a digital subtracting angiography (DSA) is exported to the vessel navigator application, the DSA is displayed without subtraction. The unsubtracted images contain more anatomical information than the DSA, which may not be suitable for verification of the registration of a pre-operative CT/MR with x-ray images during the live guidance step.

Affected products

A. 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

B. 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

C. 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