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MULTIDIAGNOST ELEVA, OMINIDOIAGNOST ELEVA, ALLURA XPER VARIOUS MODELS
- Starting date:
- August 16, 2016
- 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-60066
Affected Products
- MULTIDIAGNOST ELEVA - IMAGE INTENSIFIER - TV IMAGE DETECTOR
- MULTIDIAGNOST ELEVA - FLAT DETECTOR - IMAGE DETECTOR
- ALLURA XPER FD10/10 - MAIN UNIT
- ALLURA XPER FD20/10 SYSTEM - MAIN UNIT
- ALLURA XPER FD20/20
- OMNIDIAGNOST ELEVA
- ALLURA XPER FD10
- ALLURA XPER FD20 SYSTEM - MAIN UNIT
- ALLURA XPER FD20 OR TABLE
Reason
Philips Healthcare has discovered through customer feedback, a system restart failure as a result of a blown fuse. The fuse was blown due to an unexpected main power failure in the hospital in which the uninterruptible power supply (UPS) took over.
Philips discovered after internal investigation that in time the fuse degrades.
The degrading depends on the initial value of the fuse, the current through the fuse, a continuous high operating temperature, the environmental temperature and the time the system is operational.
After degradation, the blowing of the fuse may be triggered by an unexpected main power failure as described above.
Affected products
A. MULTIDIAGNOST ELEVA - IMAGE INTENSIFIER - TV IMAGE DETECTOR
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
0708MD02
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684
NETHERLANDS
B. MULTIDIAGNOST ELEVA - FLAT DETECTOR - IMAGE DETECTOR
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
0708MD02
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684
NETHERLANDS
C. ALLURA XPER FD10/10 - MAIN UNIT
Lot or serial number
154
215
306
307
40
405
449
489
Model or catalog number
ALLURA XPER FD10/10
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684
NETHERLANDS
D. ALLURA XPER FD20/10 SYSTEM - MAIN UNIT
Lot or serial number
168
283
37
52
567
57
Model or catalog number
ALLURA XPER FD20/10
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684
NETHERLANDS
E. ALLURA XPER FD20/20
Lot or serial number
171
607
Model or catalog number
ALLURA XPER FD20/20
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684
NETHERLANDS
F. OMNIDIAGNOST ELEVA
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
708027
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684
NETHERLANDS
G. 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
Best
5684
NETHERLANDS
H. 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
Best
5684
NETHERLANDS
I. ALLURA XPER FD20 OR TABLE
Lot or serial number
146,33
Model or catalog number
454
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684
NETHERLANDS