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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