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Brilliance Products
- Starting date:
- December 19, 2012
- Posting date:
- January 21, 2013
- 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-16831
Recalled Products
- Brilliance Computed Tomography System – (6,10, 16, Slice)
- Brilliance 40/64 Slice CT System
- Brilliance CT Big Bore System – Main Unit
- Brilliance 64 Slice CT System – Main Unit
- Brilliance ICT System – System
- Brilliance Computed Tomography System
- Brilliance ICT SP System – Main
Reason
Philips Healthcare has received reports from the field stating the patient table on a system had an unexpected downward movement while a patient was on the table. Philips has determined that the cause was a malfunction of the vertical brake of the patient support due to embrittlement of the vertical brake's screws.
Affected products
A. Brilliance Computed Tomography System – (6,10, 16, Slice)
Lot or serial number
More than 10 Numbers, Contact manufacturer
Model or catalog number
4535 670 73181, 4535 670 73191
Companies
- Manufacturer
- Philips Medical Systems (Cleveland) Inc.
B. Brilliance 40/64 Slice CT System
Lot or serial number
More than 10 Numbers, Contact manufacturer
Model or catalog number
4550 11004011
Companies
- Manufacturer
- Philips Medical Systems (Cleveland) Inc.
C. Brilliance CT Big Bore System – Main Unit
Lot or serial number
More than 10 Numbers, Contact manufacturer
Model or catalog number
4535 670 88051
Companies
- Manufacturer
- Philips Medical Systems (Cleveland) Inc.
D. Brilliance 64 Slice CT System – Main Unit
Lot or serial number
More than 10 Numbers, Contact manufacturer
Model or catalog number
4550 110 00921
Companies
- Manufacturer
- Philips Medical Systems (Cleveland) Inc.
E. Brilliance ICT System – System
Lot or serial number
More than 10 Numbers, Contact manufacturer
Model or catalog number
728306
Companies
- Manufacturer
- Philips Medical Systems (Cleveland) Inc.
F. Brilliance Computed Tomography System
Lot or serial number
More than 10 Numbers, Contact manufacturer
Model or catalog number
453567005721
Companies
- Manufacturer
- Philips Medical Systems (Cleveland) Inc.
G. Brilliance ICT SP System – Main
Lot or serial number
More than 10 Numbers, Contact manufacturer
Model or catalog number
728311
Companies
- Manufacturer
- Philips Medical Systems (Cleveland) Inc.