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Vertex Epic Camera / Pegasys Ultra Imaging System (2015-03-13)
- Starting date:
- March 13, 2015
- Posting date:
- April 27, 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-53035
Recalled Products
A. Vertex Epic Camera / Pegasys Ultra Imaging System
Reason
When the Gamma camera detector #1 head is at a position directly above the patient table (relative 180 degree position), oil and/or grease contamination on the radius drive clutch (ES) may result in non-user initiated drifting down of the gamma camera, detector #1 head towards the patient table. Patient injury may result if, a patient is on the table and the downward drift is not detected in time to execute emergency patient removal.
Affected products
A. Vertex Epic Camera / Pegasys Ultra Imaging System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
AMT-VERTEXA
AMT-VERTEXE
AMT-VERTEXP
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland) Inc.
3860 NORTH FIRST STREET,
SAN JOSE, CALIFORNIA
95134
UNITED STATES