VasoNova Vascular Positioning System G4 Console Recalled for Standard Noncompliance
VasoNova is recalling 17 Vascular Positioning System G4 Consoles due to noncompliance with IEC Standard 60101-1-1.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
VasoNova, Inc. is recalling a limited number of VasoNova Vascular Positioning System (VPS) G4 Consoles. The recall involves 17 units with the catalog number VPS-G4C. These devices are indicated for the guidance and tip positioning of central venous catheters.
The recall was initiated because the affected consoles are noncompliant with International Electrotechnical Commission (IEC) Standard 60101-1-1. The agency has classified this recall as Class II.
The affected units were distributed in the United States, specifically in the states of Arizona, Georgia, Indiana, Kansas, New York, North Carolina, Pennsylvania, Virginia, and the District of Columbia. The specific serial numbers for the recalled units are GB40129, GB40130, GB40131, GB40133, GB40136, GB40146, GB40148, GB40151, GB40152, GB40154, GB40155, GB401456, GB40157, GB40158, GB40168, GB40175, and GB40186.
The recalled product
- 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.
- Manufacturer
- VasoNova, Inc.
- Hazard
- Affected units
- 17
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- Product code VPS-G4C
- Serial numbers: GB40129
- GB40130
- GB40131
- GB40133
- GB40136
- GB40146
- GB40148
- GB40151
- GB40152
- GB40154
- GB40155
- GB401456
- GB40157
- GB40158
- GB40168
- GB40175
- GB40186
Distribution
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