PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: September 10, 2014 Initiated: August 13, 2014 #Z-2571-2014

Product Description

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

Reason for Recall

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

Details

Units Affected
321 units
Distribution
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.
Location
Mountain View, CA

Frequently Asked Questions

What product was recalled?
V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 321 units.
Why was this product recalled?
Reports of deterioration of material covering the articulating section of the V5Ms transesophageal transducer.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 10, 2014. Severity: Moderate. Recall number: Z-2571-2014.