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Vertex Epic Camera / Pegasys Ultra Imaging (2014-03-07)
- Starting date:
- March 7, 2014
- Posting date:
- April 4, 2014
- 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-38803
Recalled Products
Vertex Epic Camera / Pegasys Ultra Imaging
Reason
Philips Healthcare received a report from the field about an Adac Vertex Plus system. During clinical use in the relative 180 degree configuration of the detector heads, the radius drive belt in the superior positioned head slipped off the idler pulley, allowing the detector head to drift down slowly (approximately 1 cm per minute) towards the patient. This resulted in the operator having to perform an emergency removal or the patient from the system.
Affected products
Vertex Epic Camera / Pegasys Ultra Imaging
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
AMT-VERTEXE
AMT-VERTEXP
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland) Inc.
3860 NORTH FIRST STREET,
SAN JOSE, CALIFORNIA
95134
UNITED STATES