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Philips Healthcare___February 16, 2018 FSN86100186 Medical Device Recall/Notification HeartStart FRx, HeartStart Home, and Heartstart OnSite AEDsDear HeartStart AED Owner, We are contacting you because
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How to fill out medical device recallnotification

How to fill out medical device recallnotification
01
Gather all necessary information regarding the medical device being recalled.
02
Complete the appropriate recall notification form provided by the regulatory agency.
03
Clearly state the reason for the recall and provide detailed information on the affected devices.
04
Notify customers and other stakeholders of the recall and provide instructions on how to return or dispose of the affected devices.
05
Keep detailed records of the recall process for regulatory purposes.
Who needs medical device recallnotification?
01
Manufacturers of medical devices
02
Distributors of medical devices
03
Healthcare facilities that use medical devices
04
Regulatory agencies overseeing medical devices
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What is medical device recall notification?
A medical device recall notification is a formal communication from a manufacturer or regulatory body that informs stakeholders about the removal of a defective or potentially harmful medical device from the market.
Who is required to file medical device recall notification?
Manufacturers, importers, and distributors of medical devices are required to file a medical device recall notification with the appropriate regulatory authorities.
How to fill out medical device recall notification?
To fill out a medical device recall notification, one must provide details including the product name, recall reason, number of affected units, distribution information, and instructions for customers or healthcare providers.
What is the purpose of medical device recall notification?
The purpose of a medical device recall notification is to protect public health by promptly informing users about recalled devices to prevent potential harm or adverse effects.
What information must be reported on medical device recall notification?
Information that must be reported includes the device name, model numbers, reason for recall, health risk assessment, actions taken, and instructions for affected parties.
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