Recall Z-2345-2012— Volcano Corporation
Class II · Terminated
Class II FDA medical device recall by Volcano Corporation, initiated 2012-08-24, terminated 2014-11-25. It names 2 FDA 510(k) clearances: K111706, K082229. Product: Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. Medical device for use in imaging of histology.. Reason: 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..
- Recalling firm
- Volcano Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-24
- Terminated
- 2014-11-25
- Firm location
- Rancho Cordova, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K111706 — VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM
- K082229 — S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. Medical device for use in imaging of histology.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.