V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primaril
FDA device recall Z-2571-2014 · posted 2014-09-03 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Reports of deterioration of material covering the articulating section of the V5Ms transesophageal transducer.
- Action taken
- 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
- Status
- Terminated
- Product code
- ITX
- Quantity 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, Mexi
- Date initiated
- 2014-08-13
- Date posted
- 2014-09-03
- Date terminated
- 2015-03-06
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| V5MS TRANSDUCER (K121807) | Siemens Medical Solutions USA, Inc. | 2012-07-10 |