Health product recall

Brilliance 40/60 Slice CT System, 6/10/16 Slice CT System, and CT System (16P) (2018-10-23)

Starting date:
October 23, 2018
Posting date:
November 28, 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-68420

Affected products

  1. Brilliance 40/60 Slice CT System
  2. Brilliance 6/10/16 Slice CT System
  3. Brilliance CT System (16P)

Reason

Philips has identified an issue with the front gantry cover from a particular supplier, which may impact the front gantry cover of your CT system. Some covers from this supplier may develop a problem where the fiberglass weakens at the connection point to the gantry frame causing the front cover to separate from the gantry frame, allowing it to fall.

Affected products

A. Brilliance 40/60 Slice CT System

Lot or serial number

Not applicable

Model or catalog number
  • 4550 110 04011
  • 728231
Companies
Manufacturer

Philips Medical Systems (Cleveland) Inc.

595 Miner Road

Cleveland

44143

UNITED STATES


B. Brilliance 6/10/16 Slice CT System

Lot or serial number

Not applicable

Model or catalog number
  • 4535 670 73181
  • 4535 670 78851
Companies
Manufacturer

Philips Medical Systems (Cleveland) Inc.

595 Miner Road

Cleveland

44143

UNITED STATES


C. Brilliance CT System (16P)

Lot or serial number

Not applicable

Model or catalog number
  • 453567005721
Companies
Manufacturer

Philips Medical Systems (Cleveland) Inc.

595 Miner Road

Cleveland

44143

UNITED STATES