Recall Z-1065-2018 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides t
| Date | Jan 26, 2018 |
| Status | Terminated |
| Reason | The application may underestimate the EROA (Effective Regurgitant Orifice Area) in comparison to the same patient results obtained with the 4Z1c volume transthoracic echocardiography transducer. |
| Root cause | Under Investigation by firm |
| Action | Siemens sent a Customer Notification letter to their customers. The letter identified the affected product, problem and actions to be taken. For questions contact your Customer Care Center. |
| Quantity | 564 systems |
| Distribution | Worldwide Distribution - U.S. nationwide and the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Brazil, Brunei, Canada, Chile, China, Columbia, Ecuador, Egypt, El Salvador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Malaysia, Malta, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162221 | ACUSON SC2000 Diagnostic Ultrasound System Siemens Medical Solutions Inc. Ultrasound Group, Sep 6, 2016 |