Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, including ChromaFlo and Virtu
FDA device recall Z-0168-2011 · posted 2010-11-01 · Terminated
Recall details
- Recalling firm
- Volcano Corporation
- 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.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYO
- Quantity affected
- 79 software kits
- Distribution
- Worldwide Distribution: USA, and the countries of France, Germany, Japan, and the UK.
- Date initiated
- 2010-06-29
- Date posted
- 2010-11-01
- Date terminated
- 2010-12-22
- Location
- Rancho Cordova, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM (K082229) | Volcano Corporation | 2008-10-08 |