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