Enforcement Report - Week of September 19, 2012
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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. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| 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. | All units of these models. Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02 | Class II | 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. | 1020 units | Z-2345-2012 |
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