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URGENT FIELD SAFETY NOTICED ate of Letter Deployment To:GE Healthcare 3000 N. Grandview Blvd. W440 Waukesha, WI 53188 USAGE Ref # 85460Director/Manager of Radiology Director/Manager of Cardiology
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01
Gather all necessary information regarding the safety issue or incident.
02
Complete the urgent field safety notice form accurately and thoroughly.
03
Include all relevant details such as date, time, location, and description of the safety issue.
04
Submit the filled out urgent field safety notice to the appropriate authorities or stakeholders promptly.
Who needs urgent field safety notice?
01
Any individual or organization that has identified a safety issue or incident that poses a risk to individuals or property may need an urgent field safety notice.
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What is urgent field safety notice?
Urgent field safety notice is a notification issued by a manufacturer or distributor to inform about a safety concern with a medical device.
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 are typically filled out online through regulatory authorities' portals or platforms.
What is the purpose of urgent field safety notice?
The purpose of urgent field safety notice is to alert users and stakeholders about potential risks associated with a medical device and to provide instructions on required actions.
What information must be reported on urgent field safety notice?
Information such as the nature of the safety concern, affected product details, potential risks to users, and recommended actions must be reported on urgent field safety notice.
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