Company: Fresenius Kabi USA, LLC Date of Enforcement Report: March 7, 2024 Class I PRODUCT LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. Recall Number: Z-1484-2024 REASON: Fresenius Kabi USA, LLC. is recalling their Ivenix Infusion System (IIS), LVP Software, an infusion pump software. The recall will take the form of a software...Read More

Today, FDA published a guidance paper for the use of augmented reality (AR) & virtual reality in medical devices. The information from that paper is provide below. Medical Extended Reality (XR), which includes Augmented Reality (AR) and Virtual Reality (VR), has the potential to deliver new types of treatments and diagnostics, transforming how and where...Read More