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Brilliance 40/64 Slice CT System, Ingenuity CT System (2016-08-29)
- Starting date:
- August 29, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-60148
Affected Products
- Brilliance 40/64 Slice CT System
- Ingenuity CT System
Reason
Philips has become aware that while performing high resolution head scans, the reconstructed images may exhibit degraded image quality manifested as:
- non uniformity of the image
- CT number shift, greater than 5 Hounsfield units
- reduction in gray/white matter differentiation
the issue is most severe in the high resolution mode. Philips provides factory reference pediatric scan protocols which are set to high resolution by default. Adult head scans have a factory reference protocol that defaults to standard resolution which does not experience the issue
Affected products
A. Brilliance 40/64 Slice CT System
Lot or serial number
- 10213
- 9074
- 9920
- 9923
Model or catalog number
- 4550 110 09021
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland) Inc.
595 MINER ROAD
CLEVELAND
Ohio
UNITED STATES
B. Ingenuity CT System
Lot or serial number
30003
30004
320123
32021
320227
Model or catalog number
728323
728326
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland) Inc.
595 MINER ROAD
CLEVELAND
Ohio
UNITED STATES