Recall Z-1190-2007 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Volcano Corporation
Volcano s5 Imaging system, Ultrasound pulsed echo imaging system. Product consists of the CPU, control console, monitor, printer, and patient interface module (PIM)
| Date | Aug 23, 2007 (initiated Apr 2, 2007) |
| Status | Terminated |
| Reason | During emissions testing, it was discovered that the product exceeds emissions limits for electromagnetic compatibility. |
| Root cause | Other |
| Action | The firm notified its customers by letter beginning April 2, 2007, and started replacing the monitor with appropriate replacement parts. |
| Quantity | 351 units worldwide |
| Distribution | Product was distributed to health care facilities nationwide and to distributors in Europe (via subsidiary), Japan (via subsidiary), Latin America and Asia (third party distributors). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051920 | VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001 Volcano Corporation, Aug 19, 2005 |