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.
- Company
- Volcano Corporation
- Recall Initiated
- August 24, 2012
- Posted
- September 10, 2012
- Terminated
- November 25, 2014
- Recall Number
- Z-2345-2012
- Quantity
- 1020 units
- Firm Location
- Rancho Cordova, CA
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.
Distribution
Worldwide Distribution.
Lot / Code Info
All units of these models. Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02
Root 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.
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