Company: Fresenius Kabi USA, LLC Date of Enforcement Report: 12/16/2025 Class: I PRODUCT Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients. Recall Number: Z-0885-2026 REASON: Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death. RECALLING FIRM/MANUFACTURER: Z-0885-2026 VOLUME:...Read More

Company: GE Healthcare GmbH Date of Enforcement Report: 12/16/2025 Class: II PRODUCT GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system Recall Number: Z-0935-2026 REASON: GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information. RECALLING...Read More