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page 1 of 6TOMTEC Imaging Systems GmbHR20190012019 SEP 19URGENT Field Safety Notice TOMTECARENA Patient Data Software Issue Dear Customer, We detected a problem in the TOMTECARENA Software, that,
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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 about the safety concern
02
Clearly define the scope and impact of the safety notice
03
Identify the affected products or equipment
04
Provide detailed instructions on how to mitigate the safety concern
05
Clearly communicate the urgency and deadline for action
06
Obtain necessary approvals and sign-offs
07
Distribute the notice to all relevant stakeholders
Who needs urgent field safety notice?
01
Manufacturers of products affected by a safety concern
02
Distributors and suppliers of the affected products
03
Health and safety authorities
04
Customers who have purchased the affected products
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What is urgent field safety notice?
An urgent field safety notice is a communication issued by a company to inform healthcare professionals and patients about a potential safety issue related to a medical device or product that could pose a risk to health or safety.
Who is required to file urgent field safety notice?
Manufacturers and distributors of medical devices are required to file an urgent field safety notice when they identify issues that could affect the safety of the product.
How to fill out urgent field safety notice?
To fill out an urgent field safety notice, companies must provide necessary details such as product identification, a description of the issue, advised actions for users, and a timeline for required actions.
What is the purpose of urgent field safety notice?
The purpose of an urgent field safety notice is to alert affected stakeholders about a safety concern, provide instructions for mitigating risks, and ensure that appropriate corrective actions are taken.
What information must be reported on urgent field safety notice?
The information that must be reported includes the nature of the problem, the risk involved, product details, instructions for users, and the necessary steps to mitigate the risk.
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