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Este aviso de seguridad es urgente y está destinado a informar a los distribuidores y clientes sobre un problema de seguridad potencial relacionado con la configuración de calibración de presión
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How to fill out urgent field safety notice
How to fill out urgent field safety notice
01
Start with the date of the notice.
02
Clearly identify the medical device or product involved.
03
Describe the nature of the safety concern.
04
Provide instructions on actions to be taken by users or healthcare providers.
05
Include a deadline for compliance or response.
06
Provide contact information for further inquiries.
07
Ensure the notice is clearly formatted and easy to read.
Who needs urgent field safety notice?
01
Healthcare providers who use the product.
02
Facilities that have received the product.
03
Patients who may be affected by the product.
04
Distributors and suppliers of the product.
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What is urgent field safety notice?
An urgent field safety notice is a communication issued by a manufacturer or regulatory authority to alert users and healthcare professionals about potential safety issues with a medical device or product, particularly when there is a risk of harm to patients.
Who is required to file urgent field safety notice?
Manufacturers of medical devices or products are required to file an urgent field safety notice when they identify a safety issue that could impact patients or users.
How to fill out urgent field safety notice?
To fill out an urgent field safety notice, provide details such as the product name, description of the issue, potential risks, instructions for action, and contact information for further inquiries.
What is the purpose of urgent field safety notice?
The purpose of an urgent field safety notice is to inform and protect users and patients from potential hazards associated with a medical device or product, ensuring appropriate actions are taken to mitigate risks.
What information must be reported on urgent field safety notice?
An urgent field safety notice must report information including the product name and code, details of the safety concern, affected lots, recommended actions, and contact details for the manufacturer.
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