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 t
Check against the official notice below — it lists the full affected range.
Volcano Corporation has recalled approximately 5,875 imaging systems used in cardiology procedures worldwide, including 2,685 units in the United States. The affected systems—including the Volcano Universal (Core/Core Mobile), S5, S5i, and CORE Mobile platforms with software versions 3.2.x, 3.3, and 3.4—are subject to a recall due to an incompatibility issue with hospital network scans. In certain circumstances, these systems may encounter unexpected data from the hospital network and be forced to reboot.
The recall affects systems distributed across numerous countries including the U.S., Japan, Germany, France, Spain, India, the United Kingdom, and many others. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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 Distribution: 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, Kazak Quantity: 5875 (2685 in US; 3190 ROW) Lot/code info: Systems with software version 3.2.x, 3.3,and 3.4 and v3.4 software kits. Product Codes: 807300001-807300001-R, 804200001-E, 807300001-E,807400001, 804200001, 806300001,1807400001,804200015, 804200001-M, 807400001-R, 07300001-M, 807300015-J, 804200014-R,804200014, 807400010, 804200001-R, 806300001-R, 807300015-RF,804200001-E, 806300001-R, 806300026, 807300001-R, 806300007,807300015 Serial Numbers: 101951631001,05207007001,101950286001,05207131001,05627, 05206042001, 0520641200, 1101950547001, 101950181001, 05206363001, 101950277001, 101951298001, 05207035001,05339,101950590001, 05206734001,101950229001,05206884001,102120770001,101950240001, 101950843001,105206471001,101950244001,05206115001,05206046001 05660,05036,06804119001,05205021001,06802011001,101950285001 101950192001 06801062001 102500002001 05208721001 05208168001 101950619001 05320041001 101951238001 05206001001 05206188001 101951628001 05208457001 05028 101950239001 977299 GREG RAUCH 6942 E. HUNTING HOLLOW CT 101950614001 101951308001 05206726001 05208267001 101950671001 05208316001 05014 06802001001 06802003001 05208369001 05206949001 05208371001 06802004001 06802004001 101950678001 05206033001 06802202001 06802893001 101950045001 05303126001 06802035001 06801009001 101950178001 06801004001 06801019001 06801018001 06801063001 05304085001 05208185001 05304027001 06801731001 101950118001 101951303001 05206414001 05208001001 05031 05206441001 05656 05206054001 05206070001 06802200001 05206824001 05304084001 1019506180
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.