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October 27, 2017QIL 150014URGENT FIELD SAFETY NOTIFICATION
IMPORTANT FIELD SAFETY INFORMATION FOR THE SIFY0019 and STY0008
Olympus Small intestinal video scope SIFY0019 and Single use Spiral tube
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How to fill out urgent field safety notice
How to fill out urgent field safety notice
01
Gather all the necessary information about the safety issue that needs to be addressed in the notice.
02
Clearly state the purpose of the notice and the urgency of the situation.
03
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04
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05
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06
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Who needs urgent field safety notice?
01
Anyone who is responsible for reporting safety issues and ensuring the prompt resolution of these issues needs an urgent field safety notice. This may include safety inspectors, field technicians, supervisors, or anyone working in a field where safety incidents can occur.
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What is urgent field safety notice?
Urgent field safety notice is a communication sent by a manufacturer to inform users of a medical device about potential risks or hazards.
Who is required to file urgent field safety notice?
Manufacturers of medical devices are required to file urgent field safety notices.
How to fill out urgent field safety notice?
Urgent field safety notices should be filled out with detailed information about the potential risks, the affected devices, and the actions that need to be taken.
What is the purpose of urgent field safety notice?
The purpose of urgent field safety notice is to communicate potential risks or hazards associated with a medical device to users in a timely manner.
What information must be reported on urgent field safety notice?
Information such as the affected device, the nature of the risk, recommended actions, and contact information for further inquiries must be reported on urgent field safety notice.
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