Get the free Urgent field safety notice for ADVIA Centaur / XP / XPT / CP

Urgent Field Safety Notice CC 1817.A1.OUS July 2018Siemens Healthcare Diagnostics Inc.ADVIA Centaur ADVIA Centaur XP ADVIA Centaur XPT ADVIA Centaur CP ADVIA Centaur CKMB Calibrator Bias and Out of

How to fill out urgent field safety notice

How to fill out urgent field safety notice

1. Start by reviewing the urgent field safety notice form and familiarize yourself with the information required.
2. Provide details on the product or equipment affected by the safety issue.
3. Clearly explain the safety concern or issue that prompted the notice.
4. Include instructions on how to address the safety issue, such as steps for inspection, repair, or replacement.
5. Specify the contact information for reporting any incidents or seeking further assistance.
6. Ensure all relevant stakeholders receive a copy of the filled-out urgent field safety notice.

Who needs urgent field safety notice?

1. Manufacturers of products or equipment identified with safety issues that pose a risk to users.
2. Distributors or retailers responsible for selling the affected products to consumers.
3. Users or consumers who have purchased the products and need to be informed about the safety issue.

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What is urgent field safety notice?

An urgent field safety notice is a communication issued by a manufacturer to inform healthcare professionals and users about a situation that may affect the safety and performance of a medical device or product, typically requiring immediate attention.

Who is required to file urgent field safety notice?

The manufacturer of the medical device or product is required to file an urgent field safety notice.

How to fill out urgent field safety notice?

To fill out an urgent field safety notice, the manufacturer must provide detailed information about the issue, including the product identification, risk assessment, corrective actions, and instructions for users.

What is the purpose of urgent field safety notice?

The purpose of an urgent field safety notice is to mitigate risk by informing stakeholders of potential safety issues with a product, providing guidance on necessary actions to ensure patient safety.

What information must be reported on urgent field safety notice?

The information that must be reported includes the type of device, description of the safety issue, instructions for users, risk assessment, and corrective actions to be taken.