Recall Z-2345-2012
Volcano Corporation · initiated August 24, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: All units of these models. Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02
Reason for recall
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.
FDA-determined cause: Software design
Action taken
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.
Details
- Recall number
- Z-2345-2012
- Initiated
- August 24, 2012
- Posted by FDA
- September 10, 2012
- Terminated
- November 25, 2014
- Product code
- IYO – System, Imaging, Pulsed Echo, Ultrasonic
- Quantity
- 1020 units
- Distribution
- Worldwide Distribution.
- Recalling firm
- Volcano Corporation, Rancho Cordova, CA