ALLURA XPER FD10/10 - Main Unit, FD20/10 System-Main Unit, FD20/20, FD10, FD20 System - Main Unit, FD20 Or Table (2017-12-28)
- Starting date:
- December 28, 2017
- Posting date:
- January 29, 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-65802
Affected products
- ALLURA XPER FD10/10 - MAIN UNIT
- ALLURA XPER FD20/10 SYSTEM-MAIN UNIT
- ALLURA XPER FD20/20
- ALLURA XPER FD10
- ALLURA XPER FD20 SYSTEM - MAIN UNIT
- ALLURA XPER FD20 OR TABLE
Reason
Philips has become aware that extra monitors, so called 7th or 8th monitor, mounted on the Monitor Ceiling Suspension (MCS), might disengage from the MCS and fall down. The two small set screws securing the two gliding rods into an aluminum block of the support arm can come loose because of vibrations and forces exerted on them.
If the set screws have come loose gravity can keep the rods in position. However, if a force is exerted on the monitor pushing it forward, the monitor can topple forward. Once the monitor has toppled over it is only attached with its wires. If the monitor breaks loose of its wires it will drop on the floor.
Affected products
A. ALLURA XPER FD10/10 - MAIN UNIT
Lot or serial number
Not applicable
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
Not applicable
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 FD20/20
Lot or serial number
Not applicable
Model or catalog number
ALLURA XPER FD20/20
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
D. ALLURA XPER FD10
Lot or serial number
Not applicable
Model or catalog number
ALLURA XPER FD10
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
E. ALLURA XPER FD20 SYSTEM - MAIN UNIT
Lot or serial number
Not applicable
Model or catalog number
ALLURA XPER FD20
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
F. ALLURA XPER FD20 OR TABLE
Lot or serial number
Not applicable
Model or catalog number
000454
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS