Volcano s5 Imaging system, Ultrasound pulsed echo imaging system. Product consists of the CPU, control console, monitor, printer, and patient interface module (PIM)
FDA Recall Z-1190-2007 · Posted 2007-08-23
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Recalling FirmVolcano Corporation
Recall StatusTerminated
Product CodeIYO
Date Initiated2007-04-02
Date Terminated2008-06-03
Product Quantity351 units worldwide
Reason for Recall
During emissions testing, it was discovered that the product exceeds emissions limits for electromagnetic compatibility.
Firm Action
The firm notified its customers by letter beginning April 2, 2007, and started replacing the monitor with appropriate replacement parts.
Root Cause
Other
Distribution Pattern
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).
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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