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Rappel de produits de santé

Brightview XCT Imaging System-Base Gantry (2017-02-06)

Starting date:
February 6, 2017
Posting date:
February 27, 2017
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-62388

Affected Products

  1. Brightview XCT Imaging System-Base Gantry
  2. Brightview XCT Imaging System-Base Gantry
  3. Brightview XCT Imaging System-Base Gantry

Reason

  • Issue 1 - Motion controller emit the warning message
  • Issue 2 - Door interlock switch with x ray perform
  • Issue 3 - Detector contacts head holder when performing patient unload
  • Issue 4 - Jetstream freezes during gated planar scan

Affected products

A. Brightview XCT Imaging System-Base Gantry

Lot or serial number

All lots

Model or catalog number

453560462341

Companies
Manufacturer
Philips Medical Systems (Cleveland) Inc.
595 MINER ROAD
CLEVELAND
44143
Ohio
UNITED STATES

B. Brightview XCT Imaging System-Base Gantry

Lot or serial number

All lots

Model or catalog number

453560829251

Companies
Manufacturer
Philips Medical Systems (Cleveland) Inc.
595 MINER ROAD
CLEVELAND
44143
Ohio
UNITED STATES

C. Brightview XCT Imaging System-Base Gantry

Lot or serial number

All lots

Model or catalog number

453560829271

Companies
Manufacturer
Philips Medical Systems (Cleveland) Inc.
595 MINER ROAD
CLEVELAND
44143
Ohio
UNITED STATES