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This document provides a notification regarding a potential safety issue with Omega IV and Omega V tables used in certain GE Healthcare cardiovascular X-ray imaging systems. It outlines the safety
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How to fill out urgent field safety notice
How to fill out Urgent Field Safety Notice
01
Identify the product or device affected by the safety issue.
02
Gather all relevant information regarding the issue, including the risk assessment and any potential actions needed.
03
Clearly articulate the urgency of the notice and the specific actions required by the users.
04
Include contact details for further inquiries or clarifications.
05
Distribute the notice to all medical facilities, practitioners, and patients that may be impacted by the safety issue.
06
Ensure that a record of the distribution is maintained for compliance purposes.
Who needs Urgent Field Safety Notice?
01
Healthcare providers who use or distribute the affected product.
02
Patients who may have received the product.
03
Regulatory bodies that oversee the safety of medical devices.
04
Manufacturers and distributors involved with the affected product.
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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 (UFSN) is a communication issued by manufacturers or distributors to inform users about risks associated with a medical device or product that requires prompt action to ensure safety.
Who is required to file Urgent Field Safety Notice?
Manufacturers, authorized representatives, and importers of medical devices or products are required to file an Urgent Field Safety Notice when safety issues arise that necessitate immediate attention.
How to fill out Urgent Field Safety Notice?
To fill out an Urgent Field Safety Notice, one should include details such as the product name, model, identification number, description of the issue, actions to be taken by users, and contact information for further inquiries.
What is the purpose of Urgent Field Safety Notice?
The purpose of an Urgent Field Safety Notice is to promptly inform affected parties of a safety-related issue to mitigate risks, ensure the safe use of the product, and provide guidance on corrective actions.
What information must be reported on Urgent Field Safety Notice?
The information that must be reported on an Urgent Field Safety Notice includes the device identification, nature of the safety risk, recommended actions for users, timelines for actions, and contact details for the issuing authority.
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