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Urgent Field Safety Notice
Field safety corrective action
concerning
the software of the floor stands FS 221, FS 225, FS 345
in combination with the
operating microscope HS His NEO 900 /A /A NIR
29.05.2019
Sender
MLLERWEDEL
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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 regarding the safety issue.
02
Identify the affected products and serial numbers.
03
Clearly explain the safety concern and the potential risks to the users.
04
Provide detailed instructions on how to rectify the issue or contact the appropriate party for assistance.
05
Include contact information for reporting feedback or questions.
Who needs urgent field safety notice?
01
Manufacturers of products with potential safety issues.
02
Distributors and retailers of the affected products.
03
Regulatory agencies overseeing product safety standards.
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What is urgent field safety notice?
An urgent field safety notice is a communication sent by a manufacturer or authorized representative to inform customers and users about a potential safety risk posed by a medical device or product.
Who is required to file urgent field safety notice?
Manufacturers, authorized representatives, and sometimes healthcare providers who are responsible for the distribution of a medical device are required to file an urgent field safety notice.
How to fill out urgent field safety notice?
To fill out an urgent field safety notice, include information such as the product details, the nature of the safety issue, corrective actions, and instructions for users or customers.
What is the purpose of urgent field safety notice?
The purpose of an urgent field safety notice is to ensure that relevant stakeholders are promptly informed about safety issues, thereby minimizing risks to patient safety and ensuring compliance with regulatory requirements.
What information must be reported on urgent field safety notice?
Important information includes the product identification, description of the safety issue, actions that should be taken by users, and timelines for these actions.
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