Get the free Class 2 Device Recall Philips Physiomonitoring system

Document Identification: FSNCCMA002001PHILIPSField Safety Notice (FSN) March 2021General & Specialty CareURGENT Field Safety Notice Medical Device Correction Xper Flex Cardio Physlo Monitoring System

How to fill out class 2 device recall

How to fill out class 2 device recall

1. Obtain the recall notification from the manufacturer or regulatory agency.
2. Identify the affected devices and their respective lot or serial numbers.
3. Inform customers or end-users about the recall and provide instructions on how to return or replace the devices.
4. Keep detailed records of the recall process, including communication with customers and any corrective actions taken.
5. Follow up with customers to ensure that the recalled devices have been returned or replaced.

Who needs class 2 device recall?

1. Manufacturers of class 2 medical devices
2. Regulatory agencies overseeing medical device safety
3. Healthcare facilities and providers using class 2 medical devices
4. Patients or consumers who have purchased or used class 2 medical devices

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What is class 2 device recall?

A Class 2 device recall is a market withdrawal of a medical device that is not likely to cause adverse health consequences but could lead to temporary or reversible health issues.

Who is required to file class 2 device recall?

Manufacturers, importers, and distributors 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, follow the guidelines provided by the FDA, which typically include detailing the device, the nature of the recall, actions taken, and a communication plan to notify affected parties.

What is the purpose of class 2 device recall?

The purpose of a Class 2 device recall is to remove defective or potentially harmful devices from the market to protect public health and ensure that patients are not exposed to devices that may result in temporary adverse effects.

What information must be reported on class 2 device recall?

Information that must be reported includes the device name, model number, reason for the recall, the health risks associated, the proposed remedy, and the population at risk.