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BRILLIANCE AND INGENUITY CT SYSTEMS (2015-07-30)
- Starting date:
- July 30, 2015
- Posting date:
- August 18, 2015
- 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-54688
Affected Products
- BRILLIANCE 40/64 SLICE CT SYSTEM
- INGENUITY CT SYSTEM
Reason
Some scans unexpectedly set the axial (Z axis) scan length to a greater length than the user set in the plan. The issue occurs only when the following 3 conditions are met:-the plan employs dual-surview, the plan requests either a sagittal or a coronal reconstruction, the gantry is tilted
Affected products
A. BRILLIANCE 40/64 SLICE CT SYSTEM
Lot or serial number
- 9920
- 9923
Model or catalog number
4550 110 04011
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland) Inc.
595 MINER ROAD
CLEVELAND
Ohio
UNITED STATES
B. INGENUITY CT SYSTEM
Lot or serial number
30003
30004-1
320123
32021
320227
Model or catalog number
728323
728326
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland) Inc.
595 MINER ROAD
CLEVELAND
Ohio
UNITED STATES