Recall Z-0744-04 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemans Medial Solutions USA, Inc
Acuson Cypress Echocardiography System
| Date | Jul 20, 2004 (initiated Feb 2, 2004) |
| Status | Terminated |
| Reason | software problem - mode does not appear on screen |
| Root cause | Other |
| Action | The recalling firm telephoned their direct accounts to inform them of the problem and the need to modify the software. The call were made from 2/2-16/04. The modification kits were sent to consignees via express delivery. |
| Quantity | 46 units |
| Distribution | The product was shipped to physicians and medical facilities in AZ, CA, CT, FL, IA, IL, NE, NV, NY, OH, TX, and WA. The product was also shipped to Australia, Brazil, Canada, Denmark, Germany, Italy, Japan, New Zealand, South Korea, and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021497 | CYPRESS ULTRASOUND SYSTEM Acuson Corp., Jul 9, 2002 |