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Brilliance CT Big Bore System - Main Unit (2013-12-19)
- Starting date:
- December 19, 2013
- Posting date:
- January 24, 2014
- 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-37659
Recalled products
- Brilliance CT Big Bore System - Main Unit
Reason
Philips has become aware that the Brilliance CT Big Bore was found to be out of tolerance for radio frequency emissions. Specifically, at the 48mhz frequency, the testing indicated the Brilliance CT Big Bore was 3.5 dBuV/meter higher than the applicable International Electronic Commission (IEC) 60601-1-2 standard specification.
Affected products
A. Brilliance CT Big Bore System - Main Unit
Lot or serial number
All lots
Model or catalog number
- 4535 670 88051
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES