Company: Gentuity, LLC Date of Enforcement Report: 4/16/2026 Class: II PRODUCT: Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13; Recall Number: Z-1823-2026 REASON: The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to...Read More

Company: Philips Medical Systems Date of Enforcement Report: 4/16/2026 Class: II PRODUCT: Philips Spectral CT on Rails. Model Number: 728334 Recall Number: Z-1825-2026 REASON: Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2....Read More