Company: mo-Vis BVBA Date of Enforcement Report: 9/2/2025 Class: I PRODUCT Micro Joystick R-net. Electrical wheelchair component. Recall Number: Z-2454-2025 REASON: Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick...Read More

Company: Reflexion Medical, Inc. Date of Enforcement Report: 9/2/2025 Class: II PRODUCT RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(21)X11003 (01)00860003983812(11)230530(21)X11004 (01)00860003983812(11)230811(21)X11006 (01)00860003983812(11)230410(21)X11007 (01)00860003983812(11)230803(21)X11008 (01)00860003983812(11)240528(21)X11009 (01)00860003983812(11)240820(21)X11010 (01)00860003983812(11)241107(21)X11011 (01)00860003983812(11)241206(21)X11012 The RefleXion X1 is a radiation therapy system that combines the functionality of an emission computed tomography detection system and a linear accelerator. The device is...Read More

Company: Medtronic MiniMed, Inc Date of Enforcement Report: 9/2/2025 Class: II PRODUCT InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) Recall Number: Z-2496-2025 REASON: Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a...Read More