V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications
FDA Recall Z-2571-2014 · Posted 2014-09-03
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Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeITX
Date Initiated2014-08-13
Date Terminated2015-03-06
Product Quantity321 units
Reason for Recall
Reports of deterioration of material covering the articulating section of the V5Ms transesophageal transducer.
Firm Action
Siemens sent a Customer Safety Advisory notification to all affected customers on August 13, 2014. The notification identified the product, the problem, and the action to be taken by the customer. Customers were advised that if they notice any damage or wear on their transducer, or if the transducer fails to pass the leakage current test, immediately discontinue use of the transducer and contact their local Customer Service Engineer. If they have any
questions, customers should contact their local service support person for information regarding timelines and status.
Customers were instructed to share this information with all personnel within their organization who need to be aware of this issue.
For questions regarding this recall call 650-417-8185.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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