Reported Jun 1, 2016 · Terminated
Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano…
Volcano Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Volcano Corporation · 2870 Kilgore Rd · Rancho Cordova, CA · 95670-6133
Is this the product you have?
- Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits
- CardiologyThe 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
- Lot codes and dates
49 of 49 products
Products covered by this recall Model / number Barcodes Product as published 0680106200110250000200105208721001 05208168001101950619001— 0532004100110195123800105206001001 0520618800110195162800105208457001 05028101950239001977299 GREG RAUCH 6942 E. HUNTING HOLLOW CT 10195061400110195130800105206726001 0520826700110195067100105208316001 05014 06802001001 06802003001 05208369001 05206949001 05208371001 06802004001 0680200400110195067800105206033001 06802202001 0680289300110195004500105303126001 06802035001 0680100900110195017800106801004001 06801019001 06801018001 06801063001 05304085001 05208185001 05304027001 0680173100110195011800110195130300105206414001 05208001001 05031 05206441001 05656 05206054001 05206070001 06802200001 05206824001 0530408400110195061800105667 0520832800110195163300110195061700105206062001 06801413001101950204001— 06801166001102120066001102120067001— 102120003001102120052001— 0680457800110195079500110212093900105343 05432 06801371001 06803918001 05530 05206682001 05206216001 0530409100110195162000105206063001 0680123300110195008400110195008200105206479001 056821019502350019775006804470001 05208621001 - Amount recalled
- 5875 (2685 in US; 3190 ROW)
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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