This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Multidiagnost Eleva - Flat Detector - Image Detector, Allura XPER FD10/10 - Main Unit,Allura XPER FD20/20-Main Unit,Allura XPER FD10 and Allura XPER FD20 System - Main Unit (2014-09-11)
- Starting date:
- September 11, 2014
- Posting date:
- October 1, 2014
- 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-41563
Recalled Products
A) Multidiagnost Eleva - Flat Detector - Image Detector
B) Allura XPER FD10/10 - Main Unit
C) Allura XPER FD20/20-Main Unit
D) Allura XPER FD10
E) Allura XPER FD20 System - Main Unit
Reason
Philips has become aware that if a footswitch is frequently used on an anti-fatigue mat, on a not flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or continuous inability of making live fluoroscopy images or exposures.
Affected products
A) Multidiagnost Eleva - Flat Detector - Image Detector
Lot or serial number
107
126
13
194
215
65
69
78
Model or catalog number
0708MD02
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6, 5684 PC
Best, Netherlands
B) Allura XPER FD10/10 - Main Unit
Lot or serial number
215
Model or catalog number
ALLURA XPER FD10/10
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6, 5684 PC
Best, Netherlands
C) Allura XPER FD20/20-Main Unit
Lot or serial number
527
567
607
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