Get the free Global Field Action Reportability Procedure. version 1 - mhra gov

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This document serves as a safety notice regarding a potential software limitation in the Innova 2121IQ and Innova 3131IQ Cardiovascular X-ray imaging systems that may lead to a loss of imaging functionality

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What is global field action reportability?

Global field action reportability refers to the requirement for companies or organizations to report any field actions, such as recalls or product corrections, that occur globally.

Who is required to file global field action reportability?

Companies or organizations that are responsible for manufacturing, distributing, or marketing products globally may be required to file global field action reportability. The specific requirements may vary by jurisdiction.

How to fill out global field action reportability?

Filling out global field action reportability typically involves providing details about the field action, such as the reason for the action, affected product information, scope of the action, and any corrective actions taken. The specific reporting process may vary depending on the regulatory requirements of each jurisdiction.

What is the purpose of global field action reportability?

The purpose of global field action reportability is to ensure that any potential risks or issues with products are promptly communicated to the relevant regulatory authorities and stakeholders. This helps to protect consumers and maintain product safety.

What information must be reported on global field action reportability?

The information that must be reported on global field action reportability typically includes details such as the nature of the field action, affected product identification, risk assessment, geographical coverage, root cause analysis, and any corrective actions taken. The specific reporting requirements may vary depending on the jurisdiction.

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