Volcano s5 Imaging system, Ultrasound pulsed echo imaging system. Product consists of the CPU, control console, monitor,
FDA device recall Z-1190-2007 · posted 2007-08-23 · Terminated
Recall details
- Recalling firm
- Volcano Corporation
- Reason for recall
- During emissions testing, it was discovered that the product exceeds emissions limits for electromagnetic compatibility.
- Action taken
- The firm notified its customers by letter beginning April 2, 2007, and started replacing the monitor with appropriate replacement parts.
- Root cause
- Other
- Status
- Terminated
- Product code
- IYO
- Quantity affected
- 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).
- Date initiated
- 2007-04-02
- Date posted
- 2007-08-23
- Date terminated
- 2008-06-03
- Location
- Rancho Cordova, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001 (K051920) | Volcano Corporation | 2005-08-19 |