Get the free Urgent Field Safety Notice – Fsn20213004-02 Rev 002
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This urgent notice advises clinicians of a mechanical valve timing issue in the Myocardial Companion 2 Driver System, potentially affecting cardiac output and requiring immediate actions.
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How to fill out urgent field safety notice
How to fill out urgent field safety notice
01
Start by reviewing the urgent field safety notice carefully to understand the required information.
02
Fill in the necessary details such as product name, model number, and serial number.
03
Provide a detailed description of the safety issue or concern.
04
Include any relevant supporting documentation or evidence.
05
Clearly specify any actions that need to be taken by the recipients of the notice.
06
Ensure all contact information is accurate and up to date before submitting the notice.
Who needs urgent field safety notice?
01
Manufacturers of products that pose a safety risk or concern.
02
Distributors or retailers who have sold the affected products.
03
Regulatory agencies responsible for ensuring product safety.
04
Consumers who have purchased or used the products in question.
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What is urgent field safety notice?
Urgent field safety notice is a notification issued by medical device manufacturers to inform users about potential safety issues.
Who is required to file urgent field safety notice?
Medical device manufacturers are required to file urgent field safety notices.
How to fill out urgent field safety notice?
Urgent field safety notices can be filled out by providing details about the safety issue, affected products, and recommended actions.
What is the purpose of urgent field safety notice?
The purpose of urgent field safety notice is to ensure quick actions are taken to address potential safety issues with medical devices.
What information must be reported on urgent field safety notice?
Information such as the nature of the safety issue, affected products, potential risks, and recommended actions must be reported on urgent field safety notice.
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