FDA-Device2012-09-19Class II
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.
Volcano Corporation
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.
Sold states
Worldwide Distribution.
Affected count
1020 units
Manufactured in
2870 Kilgore Rd, N/A, Rancho Cordova, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2345-2012Don't want to check this manually?
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