Siemens Medical Solutions USA, Inc.
4Z1c Matrix Array Transducer, model number 10033682, used with ACUSON SC2000 ultrasound systems, model number 10433816, manufactured by Siemens Medical Solutions, Ultrasound Business Unit, Mountain View, CA. The 4Z1c transducer is a special purpose ultrasound transducer designed to help clinicians perform adult echocardiography and pre-operative and intra-operative surgical assessments. Secondary
| Date | May 5, 2011 (initiated Jul 10, 2009) |
| Status | Terminated |
| Reason | Burn risk-- due to coolant leaks, patients may suffer burns or blisters due to increased temperature. |
| Root cause | Equipment maintenance |
| Action | A customer safety advisory notification was sent out to customers on 7/10/09, and a mandatory software update will also be conducted. |
| Quantity | 42 units |
| Distribution | Nationwide. Foreign: Japan, Italy, South Korea, Singapore, Yemen, Germany, Australia, and Greece. |
| 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 |