Allura Xper FD10/10 - Main Unit, Allura Xper FD10, Allura Xper FD20 - Main Unit and Allura Xper FD20/10 System - Main Unit (2018-07-17)
- Starting date:
- July 17, 2018
- Posting date:
- August 2, 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-67352
Affected products
- Allura Xper FD10/10 - Main Unit
- Allura Xper FD10
- Allura Xper FD20 System - Main Unit
- Allura Xper FD20/10 System - Main Unit
Reason
An incident has been reported to Philips in which the Monitor Ceiling Suspension (MCS), holding a FlexVision large screen 56-inch monitor, detached from the actuator rotor shaft. This caused the monitor to fall to the ground.
When a monitor ceiling suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.
Affected products
A. Allura Xper FD10/10 - Main Unit
Lot or serial number
More than 10 numbers, contact manufacturer.
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 FD10
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
ALLURA XPER FD10
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
C. Allura Xper FD20 System - Main Unit
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
ALLURA XPER FD20
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
D. Allura Xper FD20/10 System - Main Unit
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
ALLURA XPER FD20/10
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS