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Brilliance and Ingenuity CT Systems (2016-11-18)
- Starting date:
- November 18, 2016
- Posting date:
- December 5, 2016
- 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-61302
Affected Products
A. Brilliance 40/64 Slice CT System
B. Ingenuity CT System
Reason
Philips has received a complaint indicating that the non-gated bolus tracking clinical scan failed to initialize with the system displaying the error message "A problem has occurred- please retry. If the problem persists contact service." This resulted in the study being cancelled with a loss of bolus. If this were to re-occur, it may necessitate a rescan.
Affected products
A. Brilliance 40/64 Slice CT System
Lot or serial number
10213
9074
9920
9923
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
30003
30004
32021
320227
321123
Model or catalog number
728323
728326
Companies
- Manufacturer
-
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
595 MINER ROAD
CLEVELAND
44143
Ohio
UNITED STATES