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BRILLIANCE ICT SYSTEM AND SP SYSTEM (MAIN) (2017-11-01)
- Starting date:
- November 1, 2017
- Posting date:
- November 30, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-65260
Affected products
A. BRILLIANCE ICT SYSTEM-SYSTEM
B. BRILLIANCE ICT SYSTEM SP SYSTEM-MAIN
Reason
There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner's main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry. There is no potential for harm to the patient or operator due to this issue.
Affected products
A. BRILLIANCE ICT SYSTEM-SYSTEM
Lot or serial number
Not Applicable
Model or catalog number
728306
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland) Inc.
595 MINER ROAD
CLEVELAND
44143
Ohio
UNITED STATES
B. BRILLIANCE ICT SYSTEM SP SYSTEM-MAIN
Lot or serial number
Not Applicable
Model or catalog number
728311
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland) Inc.
595 MINER ROAD
CLEVELAND
44143
Ohio
UNITED STATES