Volcano brand Intravascular Ultrasound recall
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.
Why was Volcano brand Intravascular Ultrasound 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All units of these models. Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02
- 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.
- Recalling firm
- Volcano Corporation
- Quantity
- 1020 units
- Distribution
- Worldwide Distribution.
- Recall date
- September 19, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)