FDAFDA · Food and drugs·Recall number Z-2345-2012
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.
Published September 19, 2012 · Recall initiated: August 24, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Volcano Corporation
- Distributor
- Worldwide Distribution.
- Lot
- All units of these models. Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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