FDA-Device2016-06-01Class II

Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.

Volcano Corporation
Hazard

Volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. In specific circumstances, an impacted System will encounter unexpected data from the hospital network and be forced to reboot

Sold states
Worldwide Distribution: US (nationwide) and countries of: Japan, South Africa, Germany, Sweden, Belgium, France, Italy, Spain, India, Russian Federation, Hungary, Turkey, Poland, Portugal, Costa Rica, Finland, Great Britain, Croatia, India, Chile, Thailand, Mauritius, Iraq, Denmark, Norway, Ireland, Netherlands, Bulgaria, Czech Republic, Luxembourg, UAE, Austria, Poland, Pakistan, Sri Lanka, Kazakhstan, Slovakia, Saudi Arabia, Unite Arab Emirates, Egypt., Jordan, Kuwait, Lebanon, Bulgaria, Romania, Latvia, Lithuania, Bosnia and Herzegovina, Greece, Malta, Cyprus, Romania, Tunisia, Kenya, Algeria, Israel, Jordan, Hong Kong, Republic of Korea, Malaysia, New Zealand, Venezuela, Brazil, Philippines, Australia, Taiwan, Peru, Singapore, Panama, Mexico, Argentina, Costa Rica, Dominican Republic, China, and Paraguay,
Affected count
5875 (2685 in US; 3190 ROW)
Manufactured in
2870 Kilgore Rd, N/A, Rancho Cordova, CA, United States
Products
Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1813-2016

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