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GE Healthcare URGENT FIELD SAFETY NOTICE Date of Letter Deployment3000 N. Grandview Blvd. W440 Waukesha, WI 53188, USAGEHC Ref# 39001ROWTo: Healthcare Administrator / Risk Manager Chief of Nursing

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How to fill out class 2 device recall

01

Identify the reason for the recall and the impacted products.

02

Notify the appropriate regulatory authorities.

03

Prepare a recall strategy including communication plan.

04

Conduct thorough investigation and root cause analysis.

05

Implement the recall by notifying affected parties and providing instructions for return or disposal of the products.

06

Monitor and evaluate the effectiveness of the recall process.

Who needs class 2 device recall?

01

Manufacturers and distributors of medical devices who have identified a safety issue with their class 2 devices.

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What is class 2 device recall?

A Class 2 device recall is initiated when a medical device is found to cause temporary or reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Who is required to file class 2 device recall?

Manufacturers, importers, and distributors of medical devices are required to file a Class 2 device recall with the FDA.

How to fill out class 2 device recall?

To fill out a Class 2 device recall, one must submit a written recall notification to the FDA that includes details such as the device name, the reason for the recall, the nature of the problem, and the recall strategy.

What is the purpose of class 2 device recall?

The purpose of a Class 2 device recall is to protect public health by removing potentially harmful devices from the market to prevent any temporary or reversible health issues.

What information must be reported on class 2 device recall?

The information that must be reported includes device details, reason for the recall, risk assessment, and corrective actions being taken.

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