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FIELD SAFETY NOTICE / PRODUCT NOTIFICATION Subject: Software accuracy limitations for very small Multi-LeafCollimator (MLC) field sizes Product Reference: All Brain lab Brain SCAN and plan RT treatment
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What is field safety notice product?
Field safety notice product refers to a notification that is sent by a manufacturer or distributor of a medical device or product to inform regulators and customers about any potential safety issues or defects.
Who is required to file field safety notice product?
Manufacturers and distributors of medical devices or products are required to file field safety notice product if they become aware of any safety issues or defects that may pose a risk to users.
How to fill out field safety notice product?
To fill out a field safety notice product, manufacturers or distributors need to provide detailed information about the safety issue or defect, including its description, affected products, potential risks, and proposed actions to mitigate the risks.
What is the purpose of field safety notice product?
The purpose of a field safety notice product is to ensure that regulators and customers are promptly informed about any safety issues or defects associated with a medical device or product, in order to take necessary actions to protect users and prevent potential harm.
What information must be reported on field safety notice product?
A field safety notice product must include information such as the nature of the safety issue or defect, affected product details (model, lot number, etc.), potential risks to users, proposed corrective or preventive actions, and contact information for further inquiries or reporting.
When is the deadline to file field safety notice product in 2023?
The specific deadline to file a field safety notice product in 2023 may vary depending on the regulations and jurisdiction. It is recommended to refer to the applicable regulatory guidelines or consult with the regulatory authorities for the exact deadline.
What is the penalty for the late filing of field safety notice product?
The penalty for the late filing of a field safety notice product can vary depending on the regulations and jurisdiction. It may result in financial penalties, increased scrutiny from regulators, reputational damage, and potential legal consequences. It is important to adhere to the prescribed deadlines to ensure compliance and minimize risks.
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