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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