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Brilliance ICT System and SP System-Main (2017-09-12)
- Starting date:
- September 12, 2017
- Posting date:
- September 26, 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-64596
Affected products
- BRILLIANCE ICT SYSTEM-SYSTEM
- BRILLIANCE ICT SP SYSTE,-MAIN
Reason
Upon completion of scan procedure during bolus tracking on a Brilliance iCT with software version 4.1.6, no images were generated. This leads to unavailability of raw data for offline reconstruction.
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 SP SYSTE,-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