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This document reports on a field safety corrective action (FSCA) regarding malfunctioning hand switches used in Ziehm imaging medical devices, detailing the nature of the failure, corrective actions to be taken, and reporting protocols.

How to fill out field safety corrective action

How to fill out field safety corrective action

1. Identify the safety issue that requires correction.
2. Gather all relevant information about the field safety concern.
3. Document the events leading to the safety issue.
4. Ensure that all involved parties are notified about the safety issue.
5. Complete the field safety corrective action form with detailed descriptions.
6. Provide any necessary supporting documentation or evidence related to the corrective action.
7. Review the completed form for clarity and accuracy.
8. Submit the form to the designated authority for further processing.

Who needs field safety corrective action?

1. Healthcare professionals who are using the affected medical device.
2. Patients who are recipients of the medical treatment involving the device.
3. Regulatory bodies monitoring the safety and efficacy of medical devices.
4. Manufacturers responsible for the safety actions of their products.
5. Distributors and suppliers of the medical device.

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What is field safety corrective action?

Field safety corrective action refers to any action taken to prevent, reduce, or eliminate the risk associated with a safety issue in a medical device or product that has already been distributed.

Who is required to file field safety corrective action?

Manufacturers, authorized representatives, and importers of the medical device or product are required to file field safety corrective actions.

How to fill out field safety corrective action?

Field safety corrective action should be filled out by providing detailed information about the safety issue, the actions taken, the affected devices, and the communication plan to inform affected parties.

What is the purpose of field safety corrective action?

The purpose of field safety corrective action is to protect patients and users by addressing safety risks associated with medical devices and ensuring compliance with regulatory requirements.

What information must be reported on field safety corrective action?

Information reported must include details about the safety issue, the product involved, risk assessment results, corrective actions taken, and how and when the affected parties will be notified.