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GE Healthcare Urgent Field Safety Notice GE Healthcare Systems 9900 Innovation Dr. Wauwatosa, WI 53226 USA GE Healthcare Ref: FMI 60789, 67813, 67903 2010-12-03 To: Hospital Administrator/Risk Manager
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What is global field action reportability?
Global field action reportability refers to the requirement to report any actions taken in response to product defects or safety issues in all countries where the product is distributed.
Who is required to file global field action reportability?
Manufacturers, distributors, and importers of products are typically required to file global field action reportability.
How to fill out global field action reportability?
To fill out global field action reportability, the reporting entity must provide detailed information about the product, the defect or safety issue, the countries where the product is distributed, and the actions taken to address the issue.
What is the purpose of global field action reportability?
The purpose of global field action reportability is to ensure the timely identification and resolution of product defects or safety issues, in order to protect consumers from harm.
What information must be reported on global field action reportability?
Global field action reportability must include information about the product, such as its name, model number, and manufacturer, as well as details about the defect or safety issue, the countries where the product is distributed, and the actions taken to address the issue.
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