Recall Z-0168-2011 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Volcano Corporation
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.
| Date | Nov 1, 2010 (initiated Jun 29, 2010) |
| Status | Terminated |
| Reason | 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 | 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 | 79 software kits |
| Distribution | Worldwide Distribution: USA, and the countries of France, Germany, Japan, and the UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082229 | S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM Volcano Corporation, Oct 8, 2008 |