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Allura Xper Products (2016-04-05)
- Starting date:
- April 5, 2016
- Posting date:
- April 22, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-58040
Affected products
A. ALLURA XPER FD10
B. ALLURA XPER FD20 (PRODUCT OF ALLURACLARITY FAMILY)
C. ALLURA XPER FD20/20 (PRODUCT OF ALLURACLARITY FAMILY)
Reason
Philips has discovered through customer feedback and internal testing the following issues: 1. A failure with the image disk may cause the entire image processing chain to be blocked due to a SW design error. This causes image data to be lost, and eventually loss of live imaging functionality. 2. A filament error that may occur during the execution of an XperCT. When the filament error occurs, the run is aborted. After abort, new X-ray runs can be started immediately without system restart.
Affected products
A. 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
NETHERLANDS
B. ALLURA XPER FD20 (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
NETHERLANDS
C. ALLURA XPER FD20/20 (PRODUCT OF ALLURACLARITY FAMILY)
Lot or serial number
All lots
Model or catalog number
722038
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684
NETHERLANDS