Recall record at a glance
| Official record | Z-2571-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Report date | Sep 10, 2014 |
| Recall initiation date | Aug 13, 2014 |
| Quantity | 321 units |
| Location | Mountain View, CA, United States |
Official product description
V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications
Why the product was recalled
Reports of deterioration of material covering the articulating section of the V5Ms transesophageal transducer.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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