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PHILIPS Healthcare1/4FSN86100208A, FC086100210A October 2019URGENT Medical Device Correction Heart start Elf Defibrillator/Monitor (Model number 861290) Dear Customer Philips has identified that the
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How to fill out class 2 device recall
How to fill out class 2 device recall
01
Identify the reason for the recall
02
Gather all necessary information about the device being recalled
03
Notify relevant stakeholders such as healthcare providers and patients
04
Submit a report to the appropriate regulatory agency
05
Develop a corrective action plan for the recalled devices
Who needs class 2 device recall?
01
Manufacturers of medical devices
02
Distributors of medical devices
03
Healthcare facilities using the medical devices
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What is class 2 device recall?
Class 2 device recall is initiated when a product's use may cause temporary or medically reversible health consequences.
Who is required to file class 2 device recall?
The manufacturer, importer, and distributor of the medical device are required to file a class 2 device recall.
How to fill out class 2 device recall?
To fill out a class 2 device recall, the manufacturer must provide detailed information about the device, the reason for recall, and actions taken.
What is the purpose of class 2 device recall?
The purpose of class 2 device recall is to remove or correct defective or potentially harmful medical devices from the market.
What information must be reported on class 2 device recall?
The information reported on a class 2 device recall must include details about the device, the reason for recall, number of affected units, and action taken.
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