Z-0168-2011

Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, including...

Name: Z-0168-2011 Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, including...
Creator: Volcano Corporation
Published: 2010-06-29
License: https://open.fda.gov/license/

Volcano Corporation / initiated 2010-06-29 / Terminated / root cause: software

FDA source

Volcano Corporation began a recall of Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, including ChromaFlo and Virtual Histology, manufactured by Volcano... on 2010-06-29. The reason FDA records is "Software defect results in improper image brightness, which may result in introduction of artifacts, which may cause misclassification of results and affect classification of tissue types. This may result in...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0168-2011
Status: Terminated
Initiated: 2010-06-29
Posted: 2010-11-01
Terminated: 2010-12-22
Recalling firm: Volcano Corporation
Product: Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, including ChromaFlo and Virtual Histology, manufactured by Volcano Corporation of Rancho Cordova, CA.
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
Reason for recall: Software defect results in improper image brightness, which may result in introduction of artifacts, which may cause misclassification of results and affect classification of tissue types. This may result in misdiagnosis and inappropriate treatment.
Root cause tag: software
FDA root cause: Software design
Action: Volcano issued a Voluntary Recall of Volcano s5 Family Software version 3.2 letter dated June 30, 2010, identifying the software defect and actions to be taken by Volcano. Field Service Engineers will visit each site and reinstall the previous software version, which will resolve the issue. Customers can contact Volcano at 916 281-2790.
Quantity in commerce: 79 software kits
Distribution: Worldwide Distribution: USA, and the countries of France, Germany, Japan, and the UK.
Product codes and lots: Software version 3.2, Part Numbers 435-0602.01 to 05,

Product code IYO

K082229Class IIS5/s5i Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow SystemVolcano Corporation / cleared 2008-10-08

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)