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U.S. Department of Health and Human Services

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.