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Allura XPER Products
- Starting date:
- May 15, 2012
- Posting date:
- June 11, 2012
- 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-26317
Recalled Products
- Allura XPER FD10/10 – Main Unit
- Allura XPER FD20/10 System – Main Unit
- Allura XPER FD 20/20
- Allura XPER FD10
- Allura XPER FD20 System – Main Unit
Reason
There is a performance issue during initializing of application that could lead to the unavailability of the follow C-Arc function. As a consequence the function cannot be used but this will not impact patient safety.
Affected products
A. Allura XPER FD10/10 – Main Unit
Lot or serial number
- N/A
Model or catalog number
- ALLURA XPER FD10/10
Companies
- Manufacturer
- Philips Medical Systems Nederland B.V.
B. Allura XPER FD20/10 System – Main Unit
Lot or serial number
- N/A
Model or catalog number
- ALLURA XPER FD20/10
Companies
- Manufacturer
- Philips Medical Systems Nederland B.V.
C. Allura XPER FD 20/20
Lot or serial number
- N/A
Model or catalog number
- ALLURA XPER FD20/20
Companies
- Manufacturer
- Philips Medical Systems Nederland B.V.
D. Allura XPER FD10
Lot or serial number
- N/A
Model or catalog number
- ALLURA XPER FD10
Companies
- Manufacturer
- Philips Medical Systems Nederland B.V.
E. Allura XPER FD20 System – Main Unit
Lot or serial number
- N/A
Model or catalog number
- ALLURA XPER FD20
Companies
- Manufacturer
- Philips Medical Systems Nederland B.V.