TEE Transducer V5M, when used with the Acuson S2000 Ultrasound System, software versions: VA15, VA15A or VA15B; Model Nu
FDA device recall Z-1884-2011 · posted 2011-04-04 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Device function failure--When performing a TEE exam with the transducer, CW (Continuous Wave) mode is not functional. Due to work flow, this may not be apparent until the transducer is inserted into the patient's esophagus.
- Action taken
- Siemens sent a Customer Safety Advisory Notification letter on April 7, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to pass the notice on to all those within their organization who need to be aware of the issue until the corrective action is completed. For questions regarding this recall call 650-969-9112.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYO
- Quantity affected
- 61 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Switzerland, China, Czech Republic, Germany, Denmark, Great Britain, Hong Kong, Indonesia, India, Italy, South Korea,
- Date initiated
- 2009-04-07
- Date posted
- 2011-04-04
- Date terminated
- 2011-04-05
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM (K082142) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008-11-13 |