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EGE Healthcare 3000 N. Grandview Blvd. W440 Waukesha, WI 53188 Sargent Field Safety Notice Date of Letter DeploymentGEHC Ref# 22998To:Director of Clinical/Radiology Risk Manager/Hospital Administrator Director

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How to fill out urgent field safety notice

01

Gather all necessary information such as product name, model number, serial number, and reason for the safety notice.

02

Clearly outline the issue or hazard that prompted the safety notice.

03

Provide detailed instructions on how to address the issue or hazard, including any necessary steps or precautions.

04

Clearly specify the timeline for taking action and any deadlines for compliance.

05

Include contact information for further questions or assistance.

Who needs urgent field safety notice?

01

Companies or organizations that have identified a safety issue or hazard with their products and need to urgently communicate this information to customers or users.

02

Regulatory authorities or government agencies may also require urgent field safety notices to be issued in certain situations.

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What is urgent field safety notice?

Urgent Field Safety Notice is a notification issued by manufacturers or distributors of medical devices to inform users of potential risks associated with the device and actions to be taken to mitigate those risks.

Who is required to file urgent field safety notice?

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

How to fill out urgent field safety notice?

Urgent Field Safety Notice should be filled out with detailed information about the device, the identified risk, recommended actions, and contact information for further assistance.

What is the purpose of urgent field safety notice?

The purpose of urgent field safety notice is to alert users of medical devices about potential risks and provide guidance on actions to be taken to ensure safety.

What information must be reported on urgent field safety notice?

Information reported on urgent field safety notice includes device details, identified risks, recommended actions, and contact information for inquiries.

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