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.
Reported: September 19, 2012 Initiated: August 24, 2012 #Z-2345-2012
Product Description
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.
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.
Details
- Recalling Firm
- Volcano Corporation
- Units Affected
- 1020 units
- Distribution
- Worldwide Distribution.
- Location
- Rancho Cordova, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Volcano Corporation. Units affected: 1020 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 19, 2012. Severity: Moderate. Recall number: Z-2345-2012.
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