MultiDiagnost Eleva- Flat Detector-Image Detector System - 2019-12-27
- Starting date:
- December 27, 2019
- Posting date:
- January 20, 2020
- 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-72127
Last updated: 2020-01-21
Affected Products
- MultiDiagnost Eleva- Flat Detector-Image Detector
- OmniDiagnost Eleva
- Allura Xper FD10
- Allura Xper FD10(Product of Alluraclarity Family)
- Allura Xper FD20(Product of Alluraclarity Family)
- Allura Xper FD10/10(Product of Alluraclarity Family)
Reason
Philips identified that a capacitor inside the convertor of the velara x-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible anymore. The failed capacitor may produce smoke and a burning odor in the room where the generator is located. If the system is a biplane model, x-ray acquisition is still possible on the other channel. If the system is a monoplane, it cannot be used anymore until the capacitor is replaced.
Affected products
A. MultiDiagnost Eleva- Flat Detector-Image Detector
Lot or serial number
Not applicable.
Model or catalog number
0708MD02
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
B. OmniDiagnost Eleva
Lot or serial number
Not applicable.
Model or catalog number
708028
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
C. Allura Xper FD10
Lot or serial number
Not applicable.
Model or catalog number
1443
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
D. Allura Xper FD10(Product of Alluraclarity Family)
Lot or serial number
Not applicable.
Model or catalog number
722026
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
E. Allura Xper FD20(Product of Alluraclarity Family)
Lot or serial number
Not applicable.
Model or catalog number
722028
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
F. Allura Xper FD10/10(Product of Alluraclarity Family)
Lot or serial number
Not applicable.
Model or catalog number
722027
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS