- Recalling firm
- Fresenius Kabi USA, LLC
- Reason for recall
- Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.
- Affected products (lot / model / serial)
- Model Number: LVP-0004; UDI-DI: 00811505030320; All Serial/Lot Numbers:
- Units affected
- 18,444
- Distribution pattern
- Domestic: CA, CO, FL, GA, ID, IL, MD, MI, MI , MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI;
- Firm location
- North Andover, MA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2224-2026
- Recall initiated
- May 6, 2026
- FDA classification date
- May 29, 2026
- FDA report date
- June 10, 2026
- FDA event ID
- 98945
- Last updated on HTM Vibe
- July 23, 2026