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URGENT FIELD SAFETY NOTICE FCA #148 Product: Hemisphere Oximetry Cable Model Number: HEMOXSC100 Serial Numbers: See table in Acknowledgement Paramedical DEVICE RECALL MM DD, YYY Customer # Contact
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How to fill out urgent field safety notice
How to fill out urgent field safety notice
01
Identify the urgent field safety notice form that needs to be filled out.
02
Provide all necessary information related to the safety issue or concern.
03
Include details about the affected product or equipment.
04
Clearly outline the actions that need to be taken to address the safety issue.
05
Include any relevant contact information for follow-up or further assistance.
06
Review the completed form for accuracy and completeness before submitting.
Who needs urgent field safety notice?
01
Any individual or organization that has identified a safety issue or concern with a product or equipment in the field.
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What is urgent field safety notice?
Urgent field safety notice is a communication sent out to inform about potential safety issues related to a product or medical device.
Who is required to file urgent field safety notice?
Manufacturers, distributors, and authorized representatives are required to file urgent field safety notices.
How to fill out urgent field safety notice?
To fill out urgent field safety notice, one must provide detailed information about the safety concern, affected products, actions taken, and contact information.
What is the purpose of urgent field safety notice?
The purpose of urgent field safety notice is to promptly communicate safety issues and prevent potential harm to users of the product or medical device.
What information must be reported on urgent field safety notice?
Information such as product identification, description of safety issue, risk assessment, actions taken, and contact details must be reported on urgent field safety notice.
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