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Brilliance CT Big Bore System-Main Unit and Ingenuity CT System (2014-12-10)
- Starting date:
- December 10, 2014
- Posting date:
- December 23, 2014
- 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-43005
Recalled Products
- Brilliance CT Big Bore System-Main Unit
- Ingenuity CT System
Reason
A potential problem with the vertical motor/brake assembly on the patient support/couch was discovered with a specific patient support/couch manufacturing lot, which may result in uncommanded vertical patient support/couch motion. To date, there have been no reported occurrences of harm.
Affected products
A) Brilliance CT Big Bore System-Main Unit
Lot or serial number
All lots.
Model or catalog number
4535, 670, 88051
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
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES