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ALLURA XPER SYSTEMS (2015-12-16)
- Starting date:
- December 16, 2015
- Posting date:
- January 14, 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-56632
Affected Products
A. ALLURA XPER FD10/10 - MAIN UNIT
B. ALLURA XPER FD20/10 SYSTEM - MAIN UNIT
C. ALLURA XPER FD20/20
D. ALLURA XPER FD10
E. ALLURA XPER FD20 SYSTEM - MAIN UNIT
F. ALLURA XPER FD20 OR TABLE
Reason
Philips has discovered through customer feedback and internal testing a failure with the image disk causing the entire image processing chain to be blocked due to a software design error. This causes image data to be lost, and eventually loss of live imaging functionality
Affected products
A. ALLURA XPER FD10/10 - MAIN UNIT
Lot or serial number
- 53772614
- 55104885
Model or catalog number
ALLURA XPER FD10/10
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6, 5684 PC
Best, Netherlands
B. ALLURA XPER FD20/10 SYSTEM - MAIN UNIT
Lot or serial number
- 53388068
- 54178388
- 57436105
Model or catalog number
ALLURA XPER FD20/10
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6, 5684 PC
Best, Netherlands
C. ALLURA XPER FD20/20
Lot or serial number
- 53329363
- 62544258
Model or catalog number
ALLURA XPER FD20/20
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6, 5684 PC
Best, Netherlands
D. 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, 5684 PC
Best, Netherlands
E. 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, 5684 PC
Best, Netherlands
F. ALLURA XPER FD20 OR TABLE
Lot or serial number
55114616
Model or catalog number
000454
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6, 5684 PC
Best, Netherlands