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This document serves as a safety notice regarding incorrect software options for Philips lntelliVue Patient Monitors MX400/450/500/550. It provides essential information to ensure the safe use of these devices and outlines necessary actions for customers to mitigate risks associated with the software issue.
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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
Gather all relevant product information, including model numbers and serial numbers.
02
Describe the issue that prompted the urgent field safety notice clearly and concisely.
03
Outline the potential risks associated with the issue if not addressed.
04
Provide step-by-step instructions on how to resolve the issue or mitigate the risks.
05
Include contact information for further inquiries or reporting additional issues.
06
Ensure the document is clear and easy to understand for all recipients.

Who needs urgent field safety notice?

01
Healthcare professionals using the affected product.
02
Distributors and suppliers of the product.
03
Regulatory bodies overseeing the safety of medical devices.
04
Patients who may be affected by the product issue.
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An urgent field safety notice is a communication issued by a manufacturer or distributor to inform users about potential or actual safety issues with a medical device or product that may pose risks to patients or users.
Manufacturers or authorized representatives of medical devices or products are required to file an urgent field safety notice when they identify potential safety concerns that necessitate immediate action.
To fill out an urgent field safety notice, one should provide detailed information about the product, the nature of the safety issue, instructions for safe use or corrective actions, and the contact details for further inquiries.
The purpose of an urgent field safety notice is to protect public health by promptly informing users about risks associated with a product, ensuring they take necessary actions to mitigate these risks.
An urgent field safety notice must report information such as product identification details, description of the safety issue, potential risks, recommended actions for users, and any relevant timelines for corrective measures.
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Relevant keywords

Philips Field Safety Notice lntelliVue Patient Monitors MX400 MX450 software options safety issue monitoring health care professionals device software

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