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VERTEX EPIC CAMERA/PEGASUS ULTRA IMAGING SYSTEM (2015-03-16)

Starting date:
March 16, 2015
Posting date:
April 2, 2015
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-52777

Recalled Products 

VERTEX EPIC CAMERA/PEGASUS ULTRA IMAGING SYSTEM

Reason

Philips Healthcare received a report from the field that during a manual collimator exchange procedure, the operator was attempting to slide the collimator cassette containing the detector 2 vertex high resolution (VXHR) collimator from the collimator storage cabinet onto the collimator exchange carriage.  As the VXHR collimator and collimator cassette was being slid onto the carriage, the cassette did not align with the carriage top guide rollers and mechanical lock. The collimator and collimator cassette fell off of the carriage and onto the floor.

Affected products

VERTEX EPIC CAMERA/PEGASUS ULTRA IMAGING SYSTEM

Lot or serial number

All lots.

Model or catalog number
  • AMT-VERTEXA
  • AMT-VERTEXE-ULTRA
  • AMT-VERTEXP
Companies
Manufacturer
Philips Medical Systems (Cleveland) Inc.
3860 North First Street
San Jose
95134
UNITED STATES