Company:Volcano Corporation
Date of Enforcement Report 9/19/12
Class ll:
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.
Recall Number Z-2345-2012
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/MANUFACTURER
Volcano Corporation, Rancho Cordova, CA on 8/24/12. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1020 units
DISTRIBUTION
Nationwide and Internationally
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