Allura Xper FD10, FD20, FD10/10, and FD20/10 (2018-06-12)
- Starting date:
- June 12, 2018
- Posting date:
- August 17, 2018
- 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-67402
Affected products
- Allura Xper FD10
- Allura Xper FD20
- Allura Xper FD10/10
- Allura Xper FD20/10
Reason
The first time an operator selects a new procedure type during a single examination, the shutter position resets to the open position for the new procedure type. If the shutters had previously been changed during the examination, that setting is not retained after the first time the procedure type is changed during a single examination.
Affected products
A. Allura Xper FD10
Lot or serial number
- 598
- 807
- 961
- 962
- 986
- 998
- 1049
- 1115
Model or catalog number
ALLURA XPER FD10
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
B. Allura Xper FD20
Lot or serial number
- 511
- 1572
Model or catalog number
722028
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
C. Allura Xper FD10/10
Lot or serial number
296
Model or catalog number
722027
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
D. Allura Xper FD20/10
Lot or serial number
599
Model or catalog number
722029
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS