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DOC037554/01URGENT FIELD SAFETY NOTICE (FSN) MEDICAL DEVICE RECALL ICS CHART REP 200 Date: July 2019 (Customer Address City, State Zip Country) Re: SR ___ Dear Valued Customer, Information on Affected
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How to fill out urgent field safety notice

How to fill out urgent field safety notice
01
Gather all necessary information about the safety concern.
02
Create a clear and concise description of the issue.
03
Include any relevant photos or illustrations to better explain the problem.
04
Clearly state the actions that need to be taken by the recipients.
05
Include contact information for follow-up questions or concerns.
Who needs urgent field safety notice?
01
Manufacturers of products
02
Distributors of products
03
Healthcare professionals
04
Regulatory agencies
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What is urgent field safety notice?
Urgent field safety notice is a notification to inform users and relevant authorities about potential safety issues related to a medical device or equipment.
Who is required to file urgent field safety notice?
Manufacturers, importers, and distributors of medical devices are required to file urgent field safety notice.
How to fill out urgent field safety notice?
Urgent field safety notice can be filled out by providing detailed information about the safety issue, affected devices, recommended actions, and contact information for further inquiries.
What is the purpose of urgent field safety notice?
The purpose of urgent field safety notice is to ensure the safety of patients and users of medical devices by providing timely information about potential risks and recommended actions.
What information must be reported on urgent field safety notice?
Information such as the nature of the safety issue, affected device models, risk assessment, recommended actions for users, and contact information for reporting adverse events must be reported on urgent field safety notice.
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