Device 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.
Z-2345-2012
Product summary
- Event
- Event 63102
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1020 units
- Official record key
device-enforcement:Z-2345-2012
Official wording
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.
Code information: All units of these models. Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02
Distribution pattern: Worldwide Distribution.
Derived failure modes
-
Unknown
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.