Enforcement Report - Week of September 19, 2012
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Product Detail
| 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. |
|---|---|
| Recall Number | Z-2345-2012 |
| Classification | Class II |
| Code Info | All units of these models. Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02 |
| Product Distributed Qty | 1020 units |
| 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. |
Event Detail
| Event Id | 63102 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Volcano Corporation |
| City | Rancho Cordova |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-24 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution. |
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