Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-
FDA device recall Z-2345-2012 · posted 2012-09-10 · Terminated
Recall details
- Recalling firm
- Volcano Corporation
- Reason for recall
- The display on the system has the potential to change. In house testing eventually identified the unique sequence of events that must occur in order for this issue to manifest itself.
- Action taken
- Volcano Corporation sent an "IMPORTANT FIELD CORRECTIVE ACTION" letter dated August 24, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact your local Volcano sales representative or Volcano Customer Service for questions regarding this recall.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYO
- Quantity affected
- 1020 units
- Distribution
- Worldwide Distribution.
- Date initiated
- 2012-08-24
- Date posted
- 2012-09-10
- Date terminated
- 2014-11-25
- 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 |
|---|---|---|
| VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM (K111706) | Volcano Corporation | 2011-07-15 |
| S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM (K082229) | Volcano Corporation | 2008-10-08 |