Device product
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.
Z-1408-2015
Product summary
- Firm
- VasoNova, Inc.
- Event
- Event 70927
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17
- Official record key
device-enforcement:Z-1408-2015
Official wording
Reason: A limited number of VPS G4 Consoles are being recalled due to noncompliance with International Electrotechnical Commission Standard 60101-1-1.
Code information: Product code VPS-G4C; Serial numbers: GB40129, GB40130, GB40131, GB40133, GB40136, GB40146, GB40148, GB40151, GB40152, GB40154, GB40155, GB401456, GB40157, GB40158, GB40168, GB40175, GB40186
Distribution pattern: US Nationwide Distribution in the states of AZ, DC, PA, IN, PA. GA, NY, KS, CA, VA, NC.
Derived failure modes
-
Unknown
A limited number of VPS G4 Consoles are being recalled due to noncompliance with International Electrotechnical Commission Standard 60101-1-1.