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July XX, 2020 Olympus reference: OIL 153003URGENT FIELD SAFETY NOTICE RECALL OF K401 & K402 SINGLE USE GUIDE SHEATH KITS FROM THE FIELD Attention: Operating Room Manager and Risk Management Department
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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 issue
02
Determine the affected medical devices or products
03
Clearly describe the nature of the safety issue
04
Provide detailed instructions on how to mitigate the risk
05
Clearly outline the contact information for reporting the safety concern
Who needs urgent field safety notice?
01
Manufacturers of medical devices
02
Distributors of medical devices
03
Healthcare providers
04
Regulatory authorities
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What is urgent field safety notice?
Urgent field safety notice is a mandatory notification that must be filed by manufacturers, distributors, and importers in case of a serious safety concern with a medical device.
Who is required to file urgent field safety notice?
Manufacturers, distributors, and importers are required to file urgent field safety notices.
How to fill out urgent field safety notice?
Urgent field safety notices can be filled out using a standardized form provided by regulatory authorities, which includes information on the safety concern, affected devices, and proposed actions.
What is the purpose of urgent field safety notice?
The purpose of urgent field safety notice is to inform relevant parties about a serious safety concern with a medical device and to take appropriate actions to mitigate risks.
What information must be reported on urgent field safety notice?
Information that must be reported on urgent field safety notice includes details about the safety concern, affected devices, proposed actions, and contact information for further communication.
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