Company: MUNEVO GMBH Date of Enforcement Report: 7/31/2026 Class: II PRODUCT munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System Recall Number: Z-2856-2026 REASON: A software issue may cause the wheelchair’s driving mechanism to fall out of calibration. When this occurs, the device may experience unexpected steering drift...Read More
Company: Copan WASP Date of Enforcement Report: 7/31/2026 Class: II PRODUCT Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version: WebApp version 2.33.1, 2.33.3 and 2.34.2 Product Description: WASPLab is an automated device intended to be used for the incubation and the digital imaging of agar culture plates streaked with microbiological specimens derived...Read More
Company: Beckman Coulter Biomedical GmbH Date of Enforcement Report: 7/31/2026 Class: II PRODUCT REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections. Recall Number: Z-2834-2026 REASON: Due to software issues where does not handle combo assay results. The software...Read More
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