Recall Z-1813-2016
Volcano Corporation · initiated April 25, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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…
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
FDA-determined cause: Software in the Use Environment
Action taken
The firm, Philips, sent an "URGENT MEDICAL DEVICE FIELD CORRECTIVE ACTION" letter dated 4/25/2016 to its customers beginning April 29, 2016 which include a technical service bulletin to explain how to assure the incompatibility issue does not affect system performance. The customers were instructed to do the following: -If you have an Impacted System but it is not connected to a network, this issue does not affect your system. Additionally, if network scans are not performed, this issue does not affect your system. -If you have an Impacted System that is connected to a network and staff performs network scans while the Impacted System is in operation, this issue does affect you and the circumstances exist for a manual reboot to occur during an active procedure. To avoid this, the following corrections must promptly be taken: 1. Disconnect your Impacted Systems from the facilities network. If you need to reconnect it while not being used in a procedure, make sure it is disconnected again before starting any procedure; OR 2. Do not permit your staff to perform network scans while the Impacted Systems are in operation. -Please complete, sign, and return the attached form indicating that you received this Field Corrective Action notification via Fax to Volcano Customer Service at (916) 638-8812 or email to CS@volcanocorp.com. If you have any questions, please call (800) 228-4728, option 5.
Details
- Recall number
- Z-1813-2016
- Initiated
- April 25, 2016
- Terminated
- January 2, 2018
- Product code
- OBJ – Catheter, Ultrasound, Intravascular
- Quantity
- 5875 (2685 in US; 3190 ROW)
- 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…
- Recalling firm
- Volcano Corporation, Rancho Cordova, CA