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ALLURA XPER FD 10 AND FD 20 SYSTEMS (2016-02-18)
- Starting date:
- February 18, 2016
- Posting date:
- March 4, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-57410
Affected Products
- A. ALLURA XPER FD 20 SYSTEM-MAIN UNIT
- B. ALLURA XPER FD10
Reason
Philips has discovered through customer complaints and internal testing that uncontrolled geometry movements can occur when the system is not switched on/off regularly. Due to the nature of the problem the user will perceive a gradually increased sluggishness. Upon activation of the IU controls an uncontrolled geometry movement can occur. The uncontrolled movements are immediately stopped upon release of the IU controls.
Affected products
A. ALLURA XPER FD 20 SYSTEM-MAIN UNIT
Lot or serial number
All
Model or catalog number
ALLURA XPER FD20
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684
NETHERLANDS
B. ALLURA XPER FD10
Lot or serial number
All
Model or catalog number
ALLURA XPER FD10
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684
NETHERLANDS