
Get the free Class 2 Device Recall OLYMPUS TJFQ190V Duodenoscope
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Date: November XX, 2023
Olympus Reference: OIL FY24EMEA13FY24OMSC02URGENT FIELD SAFETY NOTICE
RE: OLYMPUS TJFQ190V/Q290V/Q170V DUODENOSCOPE
New Reprocessing Manuals
Required Duodenoscope Inspection
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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 of the class 2 device.
02
Notify all customers who have purchased the device about the recall.
03
Provide detailed instructions on how to return the device for evaluation or replacement.
04
Keep a record of all returned devices and document the resolution of the recall.
Who needs class 2 device recall?
01
Manufacturers of class 2 medical devices
02
Distributors of class 2 medical devices
03
Healthcare facilities that use class 2 medical devices
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What is class 2 device recall?
Class 2 device recall is a situation where a medical device is recalled from the market due to a moderate risk of causing harm to the patient.
Who is required to file class 2 device recall?
Manufacturers, distributors, and importers are required to file class 2 device recall.
How to fill out class 2 device recall?
Class 2 device recall must be filled out by providing detailed information about the reason for the recall, affected product details, and corrective actions taken.
What is the purpose of class 2 device recall?
The purpose of class 2 device recall is to remove or correct medical devices that may pose a moderate risk to patient health.
What information must be reported on class 2 device recall?
Information such as reason for recall, affected product details, distribution information, and corrective actions must be reported on class 2 device recall.
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