Recall Z-0826-2011 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
4Z1c matrix array transducer which is used with ACUSON SC2000 ultrasound system. Siemens Medical Solutions USA, Inc. Business Unit Ultrasound 1230 Shorebird Way Mountain View, CA 94043 Intended use: 4Z1 transducer is a special purpose ultrasound transducer designed to help clinicians perform adult echocardiography and pre-operative and intra-operative surgical assessments. Secondary applications
| Date | Dec 28, 2010 (initiated Sep 29, 2010) |
| Status | Terminated |
| Reason | There is the possibility of a short occurring in the transducer which could cause focal heating on the probe face. |
| Root cause | Other |
| Action | SIEMENS issued a filed correction in the form of a "Customer Safety Advisory Notification" initiated on September 29, 2010 and mailed to customers by Federal Express on the same day. The notification described the product, problem and actions to be taken by the customers. The customers were instructed to examine the 4Z1c transducer prior to use (Note: if transducer does not show a blister on its front face or does not feel unusually when it is safe for use); to immediately discontinue use and contact their local Siemens representative to get issue resolved, if the transducers developed a ho |
| Quantity | 196 units both Transducer and ACUSon SC2000 |
| Distribution | Worldwide Distribution: USA and countries including: Australia, Belgium, Brazil, China, Czech Republic, Finland, France, Germany, India, Ireland, Italy, Japan, Kenya, Malaysia, Netherlands, Norway, Portugal, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072365 | SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc., Ultrasound DI, Oct 17, 2007 |