US FDA

FDA MedWatch: Infusion Pump Software Correction: Fresenius Kabi Corrects Ivenix LVP Software for Multiple Anomalies

US FDA sent this email to their subscribers on October 1, 2024.

This device may cause serious injury or death if you continue to use it without correction.

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This device may cause serious injury or death if you continue to use it without correction. If your email program has trouble displaying this email, view as a webpage. ld }4 i [ ) 19 Bookmark and Share INFUSION PUMP SOFTWARE CORRECTION: FRESENIUS KABI USA, LLC, ISSUES CORRECTION FOR IVENIX INFUSION SYSTEM LARGE VOLUME PUMP (LVP) SOFTWARE DUE TO MULTIPLE ANOMALIES THAT MAY CAUSE DELAY OR UNDERDOSAGE OF THERAPY  Fresenius Kabi USA, LLC, is correcting the Ivenix Infusion System Large Volume Pump (LVP) software, an infusion pump software due to multiple software anomalies and a cybersecurity vulnerability that have the potential to result in delay or underdosage of therapy. Read More The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. This recall involves correcting devices and does not involve removing them from where they are used or sold. This device may cause serious injury or death if you continue to use it without correction. QUESTIONS? Customers in the U.S. with questions about this recall should contact Fresenius Kabi USA, LLC, at [email protected] or call 1-855-354-6387. - Follow us on X at @FDAMedWatch feedtwitterfacebookInstagramyoutubeflickr Manage Subscriptions  |   |  Help - This email was sent to [email protected] using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA GovDelivery logo
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