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ALLURA XPER FD20/20 (2015-08-24)
- Starting date:
- August 24, 2015
- Posting date:
- September 8, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-54920
Affected Products
A. ALLURA XPER FD20/20
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 FD20/20
Lot or serial number
65331325
Model or catalog number
ALLURA XPER FD20/20
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6, 5684 PC
Best, Netherlands