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This document provides a safety notice about a potential issue within the Centricity High Acuity Critical Care and Anesthesia systems, outlining the necessary actions that users need to take and offering
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How to fill out urgent field safety notice

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How to fill out urgent field safety notice

01
Identify the affected product and its serial numbers.
02
Gather information about the nature of the safety issue.
03
Determine the actions needed to address the safety issue.
04
Prepare a clear and concise description of the notice.
05
Include contact information for further inquiries.
06
Specify any deadlines for response or actions required.
07
Review the notice for accuracy and completeness before distribution.

Who needs urgent field safety notice?

01
Healthcare providers using the affected products.
02
Patients who may be impacted by the safety issue.
03
Regulatory authorities monitoring product safety.
04
Distributors or retailers of the affected products.
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An urgent field safety notice is a communication issued by manufacturers or regulatory authorities to inform users about safety issues related to medical devices or products that could pose risks to health.
Manufacturers and authorized representatives of the medical devices or products are required to file urgent field safety notices when they identify a safety concern that affects the performance or safety of their products.
To fill out an urgent field safety notice, include details such as the device name, description of the issue, potential risks, corrective actions, and instructions for users on how to proceed.
The purpose of an urgent field safety notice is to ensure that users are informed about safety issues promptly so that they can take appropriate actions to mitigate risks and protect patient safety.
Information that must be reported includes the device identification, nature of the safety issue, risks associated, instructions for users, and any required follow-up actions or corrections.
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