FDA-Device2014-09-10Class II

V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications

Siemens Medical Solutions USA, Inc.
Hazard

Reports of deterioration of material covering the articulating section of the V5Ms transesophageal transducer.

Sold states
Worldwide Distribution - USA (nationwide) and Internationally tAustralia, Austria, Belgium, Bolivia, Brazil, Canada, China, Columbia, France, Germany, Great Britain, India, Ireland, Italy, Japan, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Russian Federation, Saudi Arabia, Slovak Republic, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand,and United Arab Emirates.
Affected count
321 units
Manufactured in
685 E Middlefield Rd, Mountain View, CA, United States
Products
V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2571-2014

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