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Notification regarding performance issues associated with HiRes Ultra and HiRes Ultra 3D cochlear implants and corrective actions to address the problem.
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How to fill out urgent field action notification

01
Start by gathering all relevant information about the field action that needs to be notified.
02
Clearly define the nature of the issue that prompted the urgent field action.
03
Specify the product or service involved in the field action notification.
04
Indicate the date of the notification and the deadline for response or action.
05
Include contact information for personnel who can provide further details.
06
Outline the steps that recipients should take in response to the notification.
07
Ensure that the language used is clear and concise to avoid misinterpretation.
08
Review the notification for accuracy before finalizing it.

Who needs urgent field action notification?

01
Field service technicians who will be directly involved in the action.
02
Affected customers or end-users of the product or service.
03
Management for oversight and coordination of the response.
04
Regulatory bodies if the field action involves compliance issues.
05
Any other stakeholders who may be implicated or need to take action.
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An urgent field action notification is a communication issued by a company or manufacturer to inform stakeholders about a safety-related issue or defect in a product that requires immediate attention.
The manufacturer or distributor of the product that is affected by the defect or safety issue is required to file an urgent field action notification.
To fill out an urgent field action notification, you should provide detailed information about the product, the nature of the issue, the affected batch or lot, the potential risks, corrective actions taken, and instructions for the stakeholders.
The purpose of an urgent field action notification is to ensure that all relevant parties, including customers and regulatory bodies, are notified of a safety issue and to guide them on the necessary actions to mitigate any risks.
The information that must be reported includes product identification, description of the defect or safety issue, risks involved, corrective and preventive actions, distribution of affected products, and contact information for further inquiries.
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