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PRODUCTS OF ALLURACLARITY FAMILY (2016-06-28)
- Starting date:
- June 28, 2016
- Posting date:
- July 19, 2016
- 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-59380
Affected products
- ALLURA XPER FD10 (PRODUCT OF ALLURACLARITY FAMILY)
- ALLURA XPER FD20 (PRODUCT OF ALLURACLARITY FAMILY)
- ALLURA XPER FD20/20 (PRODUCT OF ALLURACLARITY FAMILY)
Reason
Philips Healthcare has discovered through trend analysis an increase in the failure rate of certain low-voltage DC power supplies ("DCPS") used in these products. Each system contains multiple DCPS, some of which may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the DCPS is powering.
Affected products
A. ALLURA XPER FD10 (PRODUCT OF ALLURACLARITY FAMILY)
Lot or serial number
- 271
- 534
Model or catalog number
- 722026
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6, 5684 PC
Best, Netherlands
B. ALLURA XPER FD20 (PRODUCT OF ALLURACLARITY FAMILY)
Lot or serial number
- 663
- 742
- 758
- 763
Model or catalog number
- 722028
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6, 5684 PC
Best, Netherlands
C. ALLURA XPER FD20/20 (PRODUCT OF ALLURACLARITY FAMILY)
Lot or serial number
- 102
- 110
- 97
Model or catalog number
- 722038
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6, 5684 PC
Best, Netherlands