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This Field Safety Notice alerts customers about a packaging issue with Nobel Biocare\'s dental devices, prompting immediate actions and device returns.
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How to fill out field safety notice
How to fill out field safety notice
01
Gather all necessary information about the product or equipment in question.
02
Clearly identify the issue or hazard that the field safety notice is addressing.
03
Provide clear instructions on how to mitigate the risk or issue.
04
Include contact information for further questions or assistance.
05
Send out the field safety notice to relevant parties.
06
Keep a record of all field safety notices sent out.
Who needs field safety notice?
01
Manufacturers of products or equipment
02
Distributors of products or equipment
03
Healthcare professionals
04
Consumers/end-users of products or equipment
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What is field safety notice?
Field safety notice is a notification sent out by a medical device manufacturer to inform users or customers about potential safety issues with a medical device.
Who is required to file field safety notice?
Medical device manufacturers are required to file field safety notices.
How to fill out field safety notice?
Field safety notices should be filled out by providing detailed information about the safety issue, affected products, and recommended actions.
What is the purpose of field safety notice?
The purpose of a field safety notice is to alert users or customers about potential safety hazards associated with a medical device and to provide instructions on how to address the issue.
What information must be reported on field safety notice?
The information reported on a field safety notice typically includes the identification of the affected product, description of the safety issue, and recommended actions for users.
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