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November XX, 2020 Olympus reference: OIL 153012URGENT FIELD SAFETY NOTICE RE: UPDATED INSTRUCTIONS FOR USE FOR SEVERAL OLYMPUS ULTRASOUND ENDOSCOPES Attention: Operating Room Manager, Risk Management
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What is urgent field safety noticefollow?
An urgent field safety notice is a communication sent to inform users and healthcare professionals about potential safety issues with a medical device or product that may affect patient health or safety.
Who is required to file urgent field safety noticefollow?
Manufacturers, authorized representatives, and importers of medical devices are typically required to file an urgent field safety notice.
How to fill out urgent field safety noticefollow?
To fill out an urgent field safety notice, one must provide details about the problem, the affected devices, recommended actions, and information on how the notice will be communicated.
What is the purpose of urgent field safety noticefollow?
The purpose of an urgent field safety notice is to protect patients by ensuring that they and relevant stakeholders are informed about safety concerns in a timely manner.
What information must be reported on urgent field safety noticefollow?
The report must include device identification, description of the issue, potential risks, actions to be taken by users, and contact information for further inquiries.
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