FDA Device recall Z-1408-2015
VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: The VPS Stylet and Console are indicated for…
- FDA Device
- Class II
- terminated
- Published 2015-04-15
On 2015-04-15 the FDA classified a Class II recall of VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: The VPS Stylet and Console are indicated for… by Vasonova, citing A limited number of VPS G4 Consoles are being recalled due to noncompliance with International Electrotechnical Commission Standard 60101-1-1.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1408-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-30 |
| Published | 2015-04-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Vasonova |
| Distribution | US |
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.
Reason
A limited number of VPS G4 Consoles are being recalled due to noncompliance with International Electrotechnical Commission Standard 60101-1-1.
Identifiers
| code_info | Product code VPS-G4C; Serial numbers: GB40129, GB40130, GB40131, GB40133, GB40136, GB40146, GB40148, GB40151, GB40152,…Product code VPS-G4C; Serial numbers: GB40129, GB40130, GB40131, GB40133, GB40136, GB40146, GB40148, GB40151, GB40152, GB40154, GB40155, GB401456, GB40157, GB40158, GB40168, GB40175, GB40186 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1408-2015%22
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