Recall Z-1961-2011 ยท ITX Transducer, Ultrasonic, Diagnostic
Siemens Medical Solutions USA, Inc.
Auxiliary 2 MHz Continuous Wave (CW) transducer, model number 8251046, when used with ACUSON Sequoia ultrasound systems at SW revision 12.X. Manufactured by Siemens Medical Solutions USA, Inc., Ultrasound Business Unit, Mountain View, CA. The ACUSON Sequoia is a general purpose Diagnostic Ultrasound system. It is intended for the following applications: Abdominal, General Imaging and Cardiology
| Date | Apr 12, 2011 (initiated Mar 21, 2009) |
| Status | Terminated |
| Reason | Overheating. A software bug may cause the transducer to overheat when used with certain transducer models. The transducer can become noticeably hot within a few minutes, which may cause patient discomfort or burns. |
| Root cause | Software design |
| Action | The firm, SIEMENS, sent a "Customer Safety Advisory Notification" to its customers on 3/21/2009. The notification described the product, problem and actions to be taken. The customers were instructed to disconnect any transducers that may be in an active transducer port and chose another imaging transducer prior to use of the Aux CW transducer. If they do not have another transducer to select other than those listed in the notification, they should close the study in progress and start a new study before using the Aux CW transducer-this procedure should be followed for each new patient and / |
| Quantity | 2591 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063085 | MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc., Nov 14, 2006 |