Ivenix Infusion System LVP Software Display May Freeze Unresponsive
Fresenius Kabi is recalling the Ivenix Infusion System (IIS) LVP Software version 5.2.0 because the display screen may freeze and become unresponsive, stopping medication flow and requiring immediate clinician intervention.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a medical device (infusion system) where the defect directly causes cessation of critical medication/fluid delivery requiring immediate clinical intervention, meeting the Severe threshold for device recalls with risk of serious patient harm.
Plain-English summary
Fresenius Kabi USA, LLC is recalling the Ivenix Infusion System (IIS), LVP Software version 5.2.0 (UDI-DI: 00811505030122). The display screen may become frozen and unresponsive to user input. When this occurs, an alarm condition is triggered, indicated by a buzzer sound and flashing red LEDs; however, the frozen display does not show the alarm status or respond to input.
This defect can result in temporary cessation of medication or fluid flow, requiring immediate intervention by the clinician to restore infusion. The issue poses a risk of interrupted drug or fluid delivery during critical care administration.
The affected units were distributed domestically to New Jersey and Wisconsin. Approximately 4 instances of this software version are involved in this recall.
The recalled product
- Product
- Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
- Manufacturer
- Fresenius Kabi USA, LLC
- Affected units
- 4
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 (1)
- UDI-DI: 00811505030122 version 5.2.0
Distribution
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