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Brilliance 40/64 Slice and Ingenuity CT Systems (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:
- Hospitals, General Public, Healthcare Professionals
- Identification number:
- RA-64592
Affected products
- BRILLIANCE 40/64 SLICE CT SYSTEM
- INGENUITY CT SYSTEM
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 40/64 SLICE CT SYSTEM
Lot or serial number
All lots
Model or catalog number
- 728231
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland) Inc.
595 MINER ROAD
CLEVELAND
44143
Ohio
UNITED STATES
B. INGENUITY CT SYSTEM
Lot or serial number
All lots
Model or catalog number
- 728323
- 728326
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland) Inc.
595 MINER ROAD
CLEVELAND
44143
Ohio
UNITED STATES