Recall Z-2571-2014 ยท ITX Transducer, Ultrasonic, Diagnostic
Siemens Medical Solutions USA, Inc.
V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications
| Date | Sep 3, 2014 (initiated Aug 13, 2014) |
| Status | Terminated |
| Reason | Reports of deterioration of material covering the articulating section of the V5Ms transesophageal transducer. |
| Root cause | Under Investigation by 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 instructe |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121807 | V5MS TRANSDUCER Siemens Medical Solutions USA, Inc., Jul 10, 2012 |