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Terminated

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.

FDA Recall Z-0168-2011 · Posted 2010-11-01

Recalling FirmVolcano Corporation
Recall StatusTerminated
Product CodeIYO
Date Initiated2010-06-29
Date Terminated2010-12-22
Product Quantity79 software kits

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution: USA, and the countries of France, Germany, Japan, and the UK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082229S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEMVolcano Corporation · 2008-10-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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