Health product recall

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