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GE Healthcare URGENT FIELD SAFETY NOTICE August 31, 2009, To: Sent Advantage Customers Hospital Administrators / Risk Managers Radiology Department Managers Sent Advantage Workstation 1.x: Inaccurate
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What is global field action reportability?
Global field action reportability is a regulatory requirement that involves reporting any actions or events related to product safety or performance that have occurred in the field globally.
Who is required to file global field action reportability?
Manufacturers, distributors, or any entities involved in the supply chain of the affected products are required to file global field action reportability.
How to fill out global field action reportability?
To fill out global field action reportability, you must gather all relevant information regarding the product, including details about the event, affected parties, geographical spread, and any remedial actions taken. This information needs to be accurately recorded in the designated report forms provided by the regulatory authority.
What is the purpose of global field action reportability?
The purpose of global field action reportability is to ensure that product safety issues are promptly identified, investigated, and communicated across international borders. It aims to prevent or mitigate potential risks to public health and safety.
What information must be reported on global field action reportability?
The information that must be reported on global field action reportability includes but is not limited to: product details, affected parties, geographic scope, details of the event or action, potential hazards or risks, and any remedial actions taken.
When is the deadline to file global field action reportability in 2023?
The deadline to file global field action reportability in 2023 may vary depending on the specific regulations or requirements of each jurisdiction. It is recommended to consult the relevant regulatory authority or legal advisor for the exact deadline.
What is the penalty for the late filing of global field action reportability?
The penalty for the late filing of global field action reportability depends on the specific regulations and jurisdiction. It may include financial fines, legal consequences, or reputational damage to the responsible entity. It is important to comply with the filing deadlines to avoid potential penalties.
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