Allura XPER Systems (2018-03-19)
- Starting date:
- March 19, 2018
- Posting date:
- April 24, 2018
- 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-66562
Affected products
- Allura Xper FD10/10 - Main Unit
- Allura Xper FD20/10 System - Main Unit
- Allura Xper FD10
- Allura XPER FD20/20 (Product of Alluraclarity Family)
Reason
Philips has been reported instances where after a continuous operation of more than one and a half day, the image on the FlexVision large screen froze, for about 15 seconds. Thereafter, the system restored itself and was fully operational again.
Note: This is only applicable to Allura Systems and UNIQ systems with a FlexVision large screen monitor. All other monitors to the system are not affected.
Affected products
-
Allura Xper FD10/10 - Main Unit
Lot or serial number
All lots.
Model or catalog number
ALLURA XPER FD10/10
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
B. Allura Xper FD20/10 System - Main Unit
Lot or serial number
All lots.
Model or catalog number
ALLURA XPER FD20/10
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
C. Allura Xper FD10
Lot or serial number
All lots.
Model or catalog number
ALLURA XPER FD10
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
D. Allura XPER FD20/20 (Product of Alluraclarity Family)
Lot or serial number
All lots.
Model or catalog number
722028
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS