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This document provides important safety information for the Brainlab m3 micro-MLC, including recommendations for device usage and configuration to avoid radiation leakage during treatments.
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How to fill out FIELD SAFETY NOTICE / PRODUCT NOTIFICATION
01
Begin by entering the date of the notification at the top of the document.
02
Identify the product involved, including its name, model number, and serial number if applicable.
03
Describe the issue or safety concern clearly and concisely.
04
Provide details on the affected population or group that may be impacted by this issue.
05
Outline the risk associated with the issue and any potential consequences.
06
Specify the necessary actions that need to be taken by the recipients.
07
Include contact information for individuals who can provide further assistance or information.
08
Review the document for clarity and completeness before distributing it.
Who needs FIELD SAFETY NOTICE / PRODUCT NOTIFICATION?
01
Healthcare professionals who use or manage the product.
02
Patients or consumers who have received or may be affected by the product.
03
Regulatory authorities responsible for monitoring product safety.
04
Distributors and retailers who sell the product.
05
Internal staff within the manufacturer or company involved.
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People Also Ask about
What is FSN in medical terms?
Field safety notices (FSNs): are safety communications sent out by medical device manufacturers or their representatives in relation to actions that may be taken in relation to their Medical Device that is on the market.
What is a field safety notification?
A field safety notice (FSN) is an important means of communicating a field safety corrective action (FSCA) and related safety information to users. It may also be used to provide updated information about how an IVD should be used.
What is a field safety notice?
A 'field safety notice' (FSN) is an important communication about the safety of a medical device that is sent to customers by a device manufacturer, or their representative. FSNs tell you what you need to do to reduce the specified risks of using the medical device.
Is a field safety notice a recall?
Recall: it is a type of FSN where a manufacturer takes a correction or removal action to address a problem with a medical device, Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.
What are field safety notices?
A 'field safety notice' (FSN) is an important communication about the safety of a medical device that is sent to customers by a device manufacturer, or their representative. FSNs tell you what you need to do to reduce the specified risks of using the medical device.
What is an example of a field safety corrective action?
Definition of Field Safety Corrective Action (FSCA) An FSCA may include, for example: returning the device to the distributor, modifying or replacing the device, or other actions taken by the manufacturer.
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What is FIELD SAFETY NOTICE / PRODUCT NOTIFICATION?
A FIELD SAFETY NOTICE / PRODUCT NOTIFICATION is a communication issued by manufacturers to inform users about potential safety issues related to a specific product, including necessary actions to mitigate risks.
Who is required to file FIELD SAFETY NOTICE / PRODUCT NOTIFICATION?
Manufacturers, authorized representatives, and in some cases, distributors are required to file FIELD SAFETY NOTICES / PRODUCT NOTIFICATIONS when they identify a safety issue with their products.
How to fill out FIELD SAFETY NOTICE / PRODUCT NOTIFICATION?
Filling out a FIELD SAFETY NOTICE / PRODUCT NOTIFICATION typically involves indicating the product details, describing the safety issue, outlining necessary actions for users, and providing contact information for further assistance.
What is the purpose of FIELD SAFETY NOTICE / PRODUCT NOTIFICATION?
The purpose of a FIELD SAFETY NOTICE / PRODUCT NOTIFICATION is to ensure the safety and well-being of users by informing them about identified risks and providing guidance on how to avoid potential harm.
What information must be reported on FIELD SAFETY NOTICE / PRODUCT NOTIFICATION?
A FIELD SAFETY NOTICE / PRODUCT NOTIFICATION must report product identification details, description of the safety issue, actions to be taken by users, risk assessment, and contact details for the manufacturer or responsible party.
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