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GE Healthcare URGENT FIELD SAFETY NOTICED ate of Letter Deployment To:GEH Ref# 32072Director of Clinical/Radiology Risk Manager/Hospital Administrator Director of Biomedical Engineering RE:Giraffe

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How to fill out urgent field safety notice

01

Start by collecting all relevant information about the safety issue that needs to be addressed in the urgent field safety notice.

02

Clearly state the nature of the safety issue and the potential risks associated with it.

03

Provide detailed instructions on how users should respond to the safety notice, including any actions they need to take.

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Include contact information for reporting any incidents or seeking further assistance related to the safety issue.

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Distribute the urgent field safety notice to all relevant stakeholders, ensuring that it reaches them in a timely manner.

Who needs urgent field safety notice?

01

Anyone who is responsible for distributing or communicating safety information to users of a product or service.

02

Organizations or companies that have identified a safety issue with one of their products and need to alert users about it quickly.

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What is urgent field safety notice?

Urgent field safety notices are notifications issued by manufacturers or distributors of medical devices regarding potential risks or hazards associated with the use of their products.

Who is required to file urgent field safety notice?

Manufacturers or distributors of medical devices are required to file urgent field safety notices.

How to fill out urgent field safety notice?

Urgent field safety notices can be filled out online or submitted through designated regulatory authorities.

What is the purpose of urgent field safety notice?

The purpose of urgent field safety notices is to inform healthcare professionals and patients about potential risks associated with a medical device.

What information must be reported on urgent field safety notice?

Information such as the nature of the safety issue, affected products, potential risks, and recommended actions must be reported on urgent field safety notices.

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