Brilliance 6/10/16 Slice CT System (2018-04-02)
- Starting date:
- April 2, 2018
- Posting date:
- April 24, 2018
- 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-66560
Affected products
Brilliance 6/10/16 Slice CT System
Reason
Philips internal evaluation determined that it is possible for the couch with head holder mounted to collide with the shelter wall on a system with the Depmed option (453567400741 Depmed Hardening Kit, Brilliance 16/16p, 459800191351 Depmed Hardening Kit for br64) when the couch is moved through the bore past the gantry.
Affected products
Brilliance 6/10/16 Slice CT System
Lot or serial number
- SN 6352
Model or catalog number
- 4535 670 78851
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland) Inc.
595 Miner Road
Cleveland
44143
UNITED STATES