Recall Z-1143-2026 — Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), and Q
U.S. FDA — Device Enforcement · United States · 2025-10-24 · Class II
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Reported risk: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
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