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Health product recall

Philips Brilliance and Ingenuity Systems (2016-02-12)

Starting date:
February 12, 2016
Posting date:
March 10, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Healthcare Professionals, General Public, Hospitals
Identification number:
RA-57460

Affected products

  1. BRILLIANCE 40/64 SLICE CT SYSTEM
  2. BRILLIANCE ICT SYSTEM - SYSTEM
  3. BRILLIANCE ICT SP SYSTEM - MAIN
  4. INGENUITY CT SYSTEM

Reason

Philips has become aware that on the affected CT systems and software versions, the issue relates to the auto transfer to the remote devices (such as PACS), where there is a possibility for intermittent failures to send all images/data series automatically.

Affected products

  1. BRILLIANCE 40/64 SLICE CT SYSTEM

Lot or serial number
  • 10213
  • 9074
  • 9920
  • 9923
Model or catalog number
  • 4550 110 09021
Companies
Manufacturer
Philips Medical Systems (Cleveland) Inc.
595 MINER ROAD
CLEVELAND
Ohio
UNITED STATES

B. BRILLIANCE ICT SYSTEM - SYSTEM

Lot or serial number

100101
100195
100619
100638

Model or catalog number

728306

Companies
Manufacturer
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
595 MINER ROAD
CLEVELAND
44143
Ohio
UNITED STATES

C. BRILLIANCE ICT SP SYSTEM - MAIN

Lot or serial number

200208

Model or catalog number

728311

Companies
Manufacturer
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
595 MINER ROAD
CLEVELAND
44143
Ohio
UNITED STATES

D. INGENUITY CT SYSTEM

Lot or serial number

30003
30004-1
320227

Model or catalog number

728323
728326

Companies
Manufacturer
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
595 MINER ROAD
CLEVELAND
44143
Ohio
UNITED STATES

Date modified: