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Volcano Corporation recalls Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-
Recalled September 19, 2012 · FDA recall Z-2345-2012 · Volcano
Hazard
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. · FDA Class II
Units
1020 units
Sold at
Worldwide Distribution.
Description
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.
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.
Manufacturer(s)
Volcano Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →