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Ref.no: GD11594 Rev URGENT FIELD SAFETY NOTICE Ge tinge FLOW, Automated Endoscope Re processor (AER) Date:01Jul2022Product Issue:Temperature not reached FLOW, CAP 627769Affected Product:FLOW AER,
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How to fill out field safety notice
How to fill out field safety notice
01
Review the field safety notice form provided by the manufacturer.
02
Fill out all required fields on the form accurately.
03
Include any relevant product information such as serial numbers or lot numbers.
04
Provide details of the safety issue or defect being reported.
05
Submit the completed form according to the instructions provided by the manufacturer.
Who needs field safety notice?
01
Manufacturers of medical devices
02
Healthcare providers
03
Regulatory agencies overseeing medical device safety
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What is field safety notice?
A field safety notice is a communication sent out by a manufacturer or distributor to inform users of a medical device of any safety issues or actions that need to be taken.
Who is required to file field safety notice?
Manufacturers or distributors of medical devices are required to file field safety notices.
How to fill out field safety notice?
To fill out a field safety notice, manufacturers or distributors must provide detailed information about the safety issue, actions to be taken, affected product details, and contact information.
What is the purpose of field safety notice?
The purpose of a field safety notice is to communicate safety issues with medical devices to users so that appropriate actions can be taken to mitigate risks.
What information must be reported on field safety notice?
Information such as the safety issue, affected product details, actions to be taken, and contact information must be reported on a field safety notice.
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