Recall Z-2345-2012 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Volcano Corporation
Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. Medical device for use in imaging of histology.
| Date | Sep 10, 2012 (initiated Aug 24, 2012) |
| Status | Terminated |
| Reason | The display on the system has the potential to change. In house testing eventually identified the unique sequence of events that must occur in order for this issue to manifest itself. |
| Root cause | Software design |
| Action | Volcano Corporation sent an "IMPORTANT FIELD CORRECTIVE ACTION" letter dated August 24, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact your local Volcano sales representative or Volcano Customer Service for questions regarding this recall. |
| Quantity | 1020 units |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |