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PHI LI PS Philips Healthcare1/4FSN86100l08A,FC086100l10A October 2019URGENT Medical Device Correction HeartStart XL+ Defibrillator/Monitor (Model number 861290) Dear Customer, Philips has identified
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The overview of Form HeartStart provides a summary of essential information related to the HeartStart program, including its objectives and the reporting requirements needed for compliance.
Entities or individuals participating in the HeartStart program, such as manufacturers, distributors, and healthcare organizations using HeartStart devices, are required to file the overview.
To fill out the overview of Form HeartStart, gather all necessary information about your participation in the program, follow the provided guidelines, and ensure that all sections are completed accurately before submission.
The purpose of the overview of Form HeartStart is to ensure that all stakeholders provide necessary data regarding the use, distribution, and compliance of HeartStart devices, facilitating safety and regulation.
Required information includes the entity's details, device specifications, usage statistics, compliance with safety standards, and any incidents or reports related to the use of HeartStart products.
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