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ALLURA XPER SYSTEMS (2016-03-10)
- Starting date:
- March 10, 2016
- Posting date:
- March 29, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-57666
Affected products
- ALLURA XPER FD10/10 - Main Unit
- ALLURA XPER FD20/10 SYSTEM - Main Unit
- ALLURA XPER FD20/20
- ALLURA XPER FD10
- ALLURA XPER FD20 SYSTEM - Main Unit
- ALLURA XPER FD20 Operating Room Table
Reason
Philips Healthcare has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with Health Canada Safety Code 20A and some provincial regulations. In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound, as required in Health Canada Safety Code 20A and some provincial regulations. No injuries attributed to the problem are reported.
Affected products
A. 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
B. 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
C. ALLURA XPER FD20/20
Lot or serial number
- 171
- 607
- 97
Model or catalog number
ALLURA XPER FD20/20
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684
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
Best
5684
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
Best
5684
NETHERLANDS
F. 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