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Field Safety Notice Philips Respironics Hospital Respiratory Care Philips Respironics V680 Ventilator Market Removal (2022CCHRC013)13January 2023This document contains important updated information

How to fill out medical device recall notification

How to fill out medical device recall notification

1. Identify the specific medical device that needs to be recalled.
2. Gather all relevant information about the device, including model number, lot number, and reason for the recall.
3. Contact the appropriate regulatory agency to report the recall and obtain a recall notification form.
4. Fill out the recall notification form completely and accurately, including details about the device, reason for the recall, and any actions that need to be taken by customers.
5. Submit the completed recall notification form to the regulatory agency and follow up to ensure that all necessary steps are taken.

Who needs medical device recall notification?

1. Manufacturers of medical devices
2. Distributors of medical devices
3. Healthcare facilities that use medical devices
4. Healthcare providers who prescribe or administer medical devices
5. Patients who have received or may receive a recalled medical device

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What is medical device recall notification?

Medical device recall notification is a process by which manufacturers and distributors inform the public and relevant authorities about a potential defect or safety issue with a medical device.

Who is required to file medical device recall notification?

Manufacturers and distributors of medical devices are required to file medical device recall notifications.

How to fill out medical device recall notification?

Medical device recall notifications can be filled out online through the appropriate regulatory authority's website or by submitting a written form with all relevant information.

What is the purpose of medical device recall notification?

The purpose of medical device recall notification is to alert the public and regulatory authorities about potential safety issues with medical devices and to facilitate their removal from the market.

What information must be reported on medical device recall notification?

Medical device recall notifications must include information about the specific device, the reason for the recall, potential risks, distribution information, and actions to be taken by consumers.