Recall Z-1813-2016 ยท OBJ Catheter, Ultrasound, Intravascular
Volcano Corporation
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.
| Date | Apr 25, 2016 |
| Status | Terminated |
| 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 |
| Root cause | Software in the Use Environment |
| Action | 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 perfo |
| 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 |
| FDA record | Open on fda.gov |