Company: Abbott Laboratories Date of Enforcement Report: 12/18/2025 Class: II PRODUCT Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 Recall Number: Z-0961-2026 REASON: Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay analyzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software...Read More

Company: DICOM Grid, Inc. Date of Enforcement Report: 12/18/2025 Class: II PRODUCT Intelerad InteleShare software, with ProViewer component Recall Number: Z-0941-2026 REASON: Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar reconstruction applied; Manual rotation applied,...Read More

Company: Medtronic MiniMed, Inc. Date of Enforcement Report: 12/18/2025 Class: II PRODUCT InPen App, Model/CFN Number: MMT-8061 (Android Users) Recall Number: Z-0958-2026 REASON: When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can’t choose to allow notifications to override phone settings when...Read More