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September XX, 2020 Olympus reference: OIL 153009URGENT FIELD SAFETY NOTICE RECALL OF CHFCB30S CHOLEDOCHOFIBERSCOPES Attention: Endoscopy Department, Risk ManagementModel Nameserver Numbers CHOLEDOCHOFIBERSCOPE
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How to fill out field safety notice
How to fill out field safety notice
01
Obtain the necessary form for the field safety notice.
02
Fill in the required information accurately and completely.
03
Include details about the product or equipment that the notice pertains to.
04
Specify the reason for issuing the notice and any potential hazards or risks involved.
05
Submit the completed field safety notice to the appropriate regulatory authorities.
Who needs field safety notice?
01
Manufacturers of products or equipment
02
Distributors or sellers of products or equipment
03
Healthcare facilities and providers
04
Any other entity responsible for the safety of products or equipment
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What is field safety notice?
A field safety notice is a communication issued by a manufacturer or regulatory authority to inform users of a medical device or product about safety-related issues that may affect performance or patient health.
Who is required to file field safety notice?
Manufacturers of medical devices or products are required to file a field safety notice when there is a risk to patient safety or device performance.
How to fill out field safety notice?
To fill out a field safety notice, manufacturers should include details about the product, the nature of the safety issue, corrective actions to be taken, and instructions for users.
What is the purpose of field safety notice?
The purpose of a field safety notice is to ensure that all stakeholders are informed about potential safety risks, guiding them on corrective actions and protecting patient health.
What information must be reported on field safety notice?
Information that must be reported includes the product identification, description of the safety issue, risk assessment, corrective actions, and relevant timelines.
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