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Health product recall

Brilliance Products

Starting date:
December 19, 2012
Posting date:
January 21, 2013
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-16831

Recalled Products

  1. Brilliance Computed Tomography System – (6,10, 16, Slice)
  2. Brilliance 40/64 Slice CT System
  3. Brilliance CT Big Bore System – Main Unit
  4. Brilliance 64 Slice CT System – Main Unit
  5. Brilliance ICT System – System
  6. Brilliance Computed Tomography System
  7. Brilliance ICT SP System – Main

Reason

Philips Healthcare has received reports from the field stating the patient table on a system had an unexpected downward movement while a patient was on the table. Philips has determined that the cause was a malfunction of the vertical brake of the patient support due to embrittlement of the vertical brake's screws.

Affected products

A. Brilliance Computed Tomography System – (6,10, 16, Slice)

Lot or serial number

More than 10 Numbers, Contact manufacturer 

Model or catalog number

4535 670 73181, 4535 670 73191

Companies
Manufacturer
Philips Medical Systems (Cleveland) Inc.

B. Brilliance 40/64 Slice CT System

Lot or serial number

More than 10 Numbers, Contact manufacturer 

Model or catalog number

4550 11004011

Companies
Manufacturer
Philips Medical Systems (Cleveland) Inc.

C. Brilliance CT Big Bore System – Main Unit

Lot or serial number

More than 10 Numbers, Contact manufacturer 

Model or catalog number

4535 670 88051

Companies
Manufacturer
Philips Medical Systems (Cleveland) Inc.

D. Brilliance 64 Slice CT System – Main Unit

Lot or serial number

More than 10 Numbers, Contact manufacturer 

Model or catalog number

4550 110 00921

Companies
Manufacturer
Philips Medical Systems (Cleveland) Inc.

E. Brilliance ICT System – System

Lot or serial number

More than 10 Numbers, Contact manufacturer

Model or catalog number

728306

Companies
Manufacturer
Philips Medical Systems (Cleveland) Inc.

F. Brilliance Computed Tomography System

Lot or serial number

More than 10 Numbers, Contact manufacturer 

Model or catalog number

453567005721

Companies
Manufacturer
Philips Medical Systems (Cleveland) Inc.

G. Brilliance ICT SP System – Main

Lot or serial number

More than 10 Numbers, Contact manufacturer

Model or catalog number

728311

Companies
Manufacturer
Philips Medical Systems (Cleveland) Inc.