Volcano s5 Imaging system, Ultrasound pulsed echo imaging system. Product consists of the CPU, control console, monitor, printer, and patient interface module (PIM)
- Company
- Volcano Corporation
- Recall Initiated
- April 2, 2007
- Posted
- August 23, 2007
- Terminated
- June 3, 2008
- Recall Number
- Z-1190-2007
- Quantity
- 351 units worldwide
- Firm Location
- Rancho Cordova, CA
Reason for Recall
During emissions testing, it was discovered that the product exceeds emissions limits for electromagnetic compatibility.
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).
Lot / Code Info
Device listing A863634, part number 804200-100. monitor part number that is being replaced: 90X0315A. All units shipped on or before November 2005.
Root Cause
Other
Action Taken
The firm notified its customers by letter beginning April 2, 2007, and started replacing the monitor with appropriate replacement parts.
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