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This document serves as an urgent safety notice from GE Healthcare regarding a potential safety issue with the Definium 8000 and Discovery XR650 patient barrier, detailing necessary actions and contact

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What is global field action reportability?

Global field action reportability refers to the requirement for companies to report any actions taken in relation to products or services that have a potential impact on public health and safety on a global scale.

Who is required to file global field action reportability?

Companies that manufacture, distribute, or sell products or services that have a potential impact on public health and safety are required to file global field action reportability.

How to fill out global field action reportability?

To fill out global field action reportability, companies need to provide detailed information about the action taken, the products or services affected, the potential risks or hazards, and any corrective measures implemented. They may also need to submit supporting evidence or documentation.

What is the purpose of global field action reportability?

The purpose of global field action reportability is to ensure transparency and accountability in addressing potential risks or hazards associated with products or services that may affect public health and safety. It allows regulatory authorities and relevant stakeholders to track, investigate, and take necessary actions to protect the public.

What information must be reported on global field action reportability?

The information that must be reported on global field action reportability includes details about the action taken, the products or services affected, the potential risks or hazards, any injuries or incidents related to the action, and any corrective measures implemented.

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