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URGENT FIELD SAFETY NOTICE Medical Device Recall Date:Ref.: FCA20200222nd June 2020Product Name and Number:423000 Neurosis V4 Intraoperative Nerve Monitor: 444400 Neurosis V4 PreAmplifier (affected

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How to fill out urgent field safety notice

01

Gather all necessary information about the safety issue

02

Clearly identify the affected product or equipment

03

Include a description of the potential hazards

04

Provide instructions for immediate action to address the safety issue

05

Include contact information for reporting any incidents or concerns

Who needs urgent field safety notice?

01

Manufacturers, distributors, and suppliers of products or equipment that pose a safety risk

02

Consumers or end users who have purchased or are using the affected product or equipment

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What is urgent field safety notice?

Urgent field safety notice is a communication tool used to inform relevant parties about a safety concern regarding a medical device that requires immediate attention.

Who is required to file urgent field safety notice?

Manufacturers and 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 by providing detailed information about the safety concern, affected products, recommended actions, and contact information.

What is the purpose of urgent field safety notice?

The purpose of urgent field safety notice is to prevent harm to patients or users of medical devices by quickly addressing safety concerns.

What information must be reported on urgent field safety notice?

Information such as the description of the safety issue, affected product details, recommended actions, and contact information must be reported on urgent field safety notice.

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