HeartSine Technologies Ltd is recalling approximately 183,248 samaritan Public Access Defibrillators (PAD) models SAM 350P, SAM 360P, and SAM 450P due to a manufacturing defect. The issue can prevent the device from providing critical voice instructions to the rescuer during an emergency. While visual icons on the device will still work, the lack of audio guidance could cause a rescuer to delay or fail to provide life-saving therapy to a patient in cardiac arrest. Affected devices were manufactured in the United Kingdom and distributed across the United States between 2016 and 2024.
The failure of instructional voice prompts during a cardiac emergency can lead to user confusion or hesitation, potentially resulting in a significant delay in delivering a life-saving shock or no therapy being delivered at all.
Manufacturing issue corrective action
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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