Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technolog
FDA device recall Z-2135-2015 · posted 2015-07-20 · Terminated
Recall details
- Recalling firm
- Volcano Corporation
- Reason for recall
- A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
- Action taken
- Urgent Medical Device Correction letters were sent on June 22, 2015 to all affected sites via FED Ex.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYO
- Quantity affected
- A total of 4007 devices, all models
- Distribution
- Worldwide Distribution-US (nationwide) and regions in Europe and the countries of Japan, Canada, South Africa, Taiwan, Thailand, Singapore, Philippines, Australia, New Zealand, El Salvador, Malaysia,
- Date initiated
- 2015-06-22
- Date posted
- 2015-07-20
- Date terminated
- 2017-04-14
- 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 S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM (K123898) | Volcano Corporation | 2013-01-14 |