Z-1190-2007

Volcano s5 Imaging system, Ultrasound pulsed echo imaging system. Product consists of the CPU, control...

Name: Z-1190-2007 Volcano s5 Imaging system, Ultrasound pulsed echo imaging system. Product consists of the CPU, control...
Creator: Volcano Corporation
Published: 2007-04-02
License: https://open.fda.gov/license/

Volcano Corporation / initiated 2007-04-02 / Terminated

FDA source

Volcano Corporation began a recall of Volcano s5 Imaging system, Ultrasound pulsed echo imaging system. Product consists of the CPU, control console, monitor, printer, and patient interface module... on 2007-04-02. The reason FDA records is "During emissions testing, it was discovered that the product exceeds emissions limits for electromagnetic compatibility". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1190-2007
Status: Terminated
Initiated: 2007-04-02
Posted: 2007-08-23
Terminated: 2008-06-03
Recalling firm: Volcano Corporation
Product: Volcano s5 Imaging system, Ultrasound pulsed echo imaging system. Product consists of the CPU, control console, monitor, printer, and patient interface module (PIM)
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
Reason for recall: During emissions testing, it was discovered that the product exceeds emissions limits for electromagnetic compatibility.
FDA 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 in commerce: 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).
Product codes and lots: Device listing A863634, part number 804200-100. monitor part number that is being replaced: 90X0315A. All units shipped on or before November 2005.

Product code IYO

K051920Class IIVolcano S5 Imaging System, Model 804200-001Volcano Corporation / cleared 2005-08-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)