Company: Copan WASP Date of Enforcement Report: 5/21/2025 Class: II PRODUCT PhenoMATRIX Recall Number: Z-1812-2025 REASON: AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the colony count and/or morphology information from images may not accurately reflect actual plate and...Read More

Company: Copan WASP Date of Enforcement Report: 05/21/2025 Class II PRODUCT PhenoMATRIX Recall Number: Z-1812-2025 REASON: AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the colony count and/or morphology information from images may not accurately reflect actual plate and...Read More

Company: Echopixel, Inc. Date of Enforcement Report: 5/21/2025 Class II PRODUCT TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who is responsible for making all patient management decisions. The True 3D Viewer...Read More