This recall affects one LIFEPAK 20e Defibrillator/Monitor (REF 99507-000001) because an incorrect keypad was installed on the device during manufacturing. The incorrect keypad could lead to confusion or operational errors when using the device to treat patients in cardiopulmonary arrest. No incidents or injuries have been reported, and the manufacturer is coordinating with the affected facility to correct the issue.
The incorrect keypad may prevent a healthcare provider from correctly operating the defibrillator during a cardiac emergency. Any delay or error in therapy for a patient in cardiopulmonary arrest poses a high risk of serious injury or death.
The AED mode is to be used only on patients in cardiopulmonary arrest.
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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES ยท Raw API Response
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