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.
This recall has been terminated (originally issued November 1, 2010).
- Company
- Volcano Corporation
- Recall Initiated
- June 29, 2010
- Posted
- November 1, 2010
- Terminated
- December 22, 2010
- Recall Number
- Z-0168-2011
- Quantity
- 79 software kits
- Firm Location
- Rancho Cordova, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution: USA, and the countries of France, Germany, Japan, and the UK.
Lot / Code Info
Software version 3.2, Part Numbers 435-0602.01 to 05,
Root Cause
Software design
Action Taken
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.