AZURION products (2021-09-27)
- Starting date:
- September 27, 2021
- Posting date:
- October 15, 2021
- 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-76669
Last updated:
2021-10-15
Affected Products
- AZURION 7 M12
- AZURION 7 M20
- AZURION 7 B12
Reason
A problem has been identified in the Philips Azurion R2.1.X system that could pose a risk for patients. Philips has discovered that when pressing or releasing both the APC (accept) button and the Float Tabletop (Panning) button at the same time, there is a possibility that the system stops reacting to movement requests (Table lockup) and X-ray imaging becomes unavailable. This problem is caused by a software defect.
Affected products
A. AZURION 7 M12
Lot or serial number
All lots.
Model or catalog number
- 722 078
- 722 223
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
B. AZURION 7 M20
Lot or serial number
All lots.
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
All lots.
Model or catalog number
- 722 067
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS