Recall Z-0975-03 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemans Medial Solutions USA, Inc
Acuson Cypress Echocardiography System. Imaging System
| Date | Jul 2, 2003 (initiated Apr 1, 2003) |
| Status | Terminated |
| Reason | software problem - loss of data |
| Root cause | Other |
| Action | The recalling firm issued a letter dated 4/03 explaining the problem and the work around. A software upgarde is being provided free of charge to the customers. |
| Quantity | 1540 units |
| Distribution | The device was shipped to hospitals and physicians nationwide. The device was also shipped to accounts in Argentina, Australia, Austria, Belgium, Boliva, Brazil, Canada, Chile, Columbia, Costa Rica, Cypress, Denmark, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Ireland, Isra |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021497 | CYPRESS ULTRASOUND SYSTEM Acuson Corp., Jul 9, 2002 |