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This document serves as a safety notification concerning a potential hazard related to the MRU fuse in GE Healthcare's MRI systems, detailing safety instructions, affected products, and steps for
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How to fill out urgent field safety notice
How to fill out Urgent Field Safety Notice
01
Begin by clearly stating the purpose of the Urgent Field Safety Notice.
02
Identify the product or device involved in the safety issue.
03
Provide a detailed description of the nature of the safety concern.
04
Outline the recommended actions for the recipients to take.
05
Include information on how to report the issue or any related incidents.
06
Provide contact details for further assistance or questions.
07
Ensure that the notice is signed and dated by an authorized representative.
Who needs Urgent Field Safety Notice?
01
Healthcare professionals using the product or device.
02
Medical facilities that have received the affected products.
03
Regulatory authorities overseeing the safety of medical devices.
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People Also Ask about
What is a field safety notice?
Field Safety Notice. A communication sent out by a manufacturer or its representative to the device users in relation to a Field Safety Corrective Action.
What is an example of a field safety corrective action?
The FSCA may include; the return of a medical device to the supplier, device modification, device exchange, device destruction, retrofit by purchaser of manufacturer's modification or design change, advice given by manufacturer regarding the use of the device (e.g. where the device is no longer on the market or has
What is field safety?
Development of field safety plans is critical for identifying and mitigating risk in the field. These plans allow you to prepare for situations you may encounter and know how to respond. The purpose of the plan is to make sure all staff and students are not caught unprepared and are aware of hazards they may encounter.
What is a FSCA in medical devices?
A field safety corrective action (FSCA) is an action taken by a manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of an IVD that is already placed on the market.
What is a field safety notification?
A communication to customers and/or users sent out by a manufacturer or its representative in relation to a Field Safety Corrective Action.
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What is Urgent Field Safety Notice?
An Urgent Field Safety Notice is a communication issued by a manufacturer to inform users and customers about a safety issue related to a medical device, highlighting necessary actions to mitigate any potential risk.
Who is required to file Urgent Field Safety Notice?
Manufacturers of medical devices are required to file an Urgent Field Safety Notice in cases where a safety issue poses a risk to patients, users, or others that may be affected by the device.
How to fill out Urgent Field Safety Notice?
To fill out an Urgent Field Safety Notice, complete relevant sections detailing the device involved, nature of the safety issue, recommended actions for users, and any necessary reporting instructions.
What is the purpose of Urgent Field Safety Notice?
The purpose of an Urgent Field Safety Notice is to promptly inform stakeholders about safety risks, ensure quick action to prevent harm, and provide guidance on appropriate steps to take.
What information must be reported on Urgent Field Safety Notice?
The information that must be reported includes device identification, description of the safety issue, details of affected batches or lots, actions to be taken by users, and the timeline for implementing these actions.
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