FDA-Device2015-04-15Class II

VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.

VasoNova, Inc.
Hazard

A limited number of VPS G4 Consoles are being recalled due to noncompliance with International Electrotechnical Commission Standard 60101-1-1.

Sold states
US Nationwide Distribution in the states of AZ, DC, PA, IN, PA. GA, NY, KS, CA, VA, NC.
Affected count
17
Manufactured in
155 Jefferson Dr, N/A, Menlo Park, CA, United States
Products
VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1408-2015

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