Company:Volcano Corporation
Date of Enforcement Report 6/1/2016
Class lI:
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.
Recall Number Z-1813-2016
REASON
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.
RECALLING FIRM/MANUFACTURER
Volcano Corporation, Rancho Cordova, CA, on 4/25/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
5875
DISTRIBUTION
Nationwide and Internationally
___________________________________
