Ambu Inc. is recalling 11,845 Ambu aView 2 Advance medical monitors because the instructions for use were missing critical safety warnings regarding mounting hardware. If the wrong size screws are used to mount the monitor to a stand, they can puncture the internal lithium-ion battery. This defect can lead to battery leakage, smoke, and fires, potentially causing severe burns or skin irritation to patients and healthcare providers.
Using mounting screws longer than 16mm will penetrate the lithium-ion battery, resulting in a fire hazard, smoke inhalation, and leakage of battery chemicals. Conversely, using screws shorter than 14mm may result in the monitor falling from its mount.
Instructions for Use Update
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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