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Phased Array Transducer (2014-08-21)

Starting date:
August 21, 2014
Posting date:
September 11, 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-41341

Recalled Products

Phased Array Transducer 

Reason

Siemens is issuing a customer safety advisory notification regarding a potential safety risk associated with deterioration of material covering the articulating section of the V5Ms Transesophageal transducer. A compromise or fault in this material combined with a failure to use a probe cover as directed in the user manual may pose a safety risk to the patient and user. However, the potential risk is avoided only if users perform the recommended leakage current test of the transducer as specified in the user manual.

Affected products

Phased Array Transducer 

Lot or serial number

S/N S34007656

Model or catalog number

08263703

Companies
Manufacturer
Siemens Medical Solutions USA, Inc.
685 East Middlefield Road
Mountain View
94043
California
UNITED STATES