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Volcano Corporation recalls Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volca
Recalled June 1, 2016 · FDA recall Z-1813-2016 · Volcano
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 · FDA Class II
Units
5875 (2685 in US; 3190 ROW)
Sold at
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,
Description
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
Product
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.
Manufacturer(s)
Volcano Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →