Recall Z-1884-2011 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Siemens Medical Solutions USA, Inc.
TEE Transducer V5M, when used with the Acuson S2000 Ultrasound System, software versions: VA15, VA15A or VA15B; Model Numbers: 10041461 (Acuson S2000) and 8263703 (V5M Transducer); Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Mountain View, CA Product is a medical device, a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen
| Date | Apr 4, 2011 (initiated Apr 7, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 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, Norway, Turkmenistan, and Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082142 | ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc., Ultrasound DI, Nov 13, 2008 |