Devices

Device Recall Volcano brand Intravascular Ultrasound

Model / Serial
All units of these models. Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution.
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.
Manufacturer
Volcano Corporation
1 Event
- Recall of Device Recall Volcano brand Intravascular Ultrasound

Manufacturer

Volcano Corporation

Manufacturer Address
Volcano Corporation, 2870 Kilgore Rd, Rancho Cordova CA 95670-6133
Manufacturer Parent Company (2017)
Philips
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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