Get the free Class 2 Device Recall Olympus CHFCB30S Choledoscope
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September 9, 2020,
Olympus reference: OIL 153009URGENT FIELD SAFETY NOTICE
RECALL OF CHFCB30S CHOLEDOCHOFIBERSCOPES
Attention: Endoscopy Department, Risk ManagementModel Nameserver Numbers CHOLEDOCHOFIBERSCOPE
OLYMPUS
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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 and determine if it is a Class 2 device recall.
02
Notify the appropriate regulatory authorities about the recall.
03
Prepare a recall strategy and keep detailed records of the process.
04
Notify the customers about the recall and provide instructions on how to return the devices.
05
Monitor the progress of the recall and report back to the regulatory authorities.
Who needs class 2 device recall?
01
Manufacturers and distributors of medical devices who have identified a potential defect or safety issue in their Class 2 devices.
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What is class 2 device recall?
Class 2 device recall is a situation where a medical device is found to have a moderate risk of causing harm to the patient.
Who is required to file class 2 device recall?
Manufacturers, distributors, and importers of medical devices 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 responsible party must provide detailed information about the device, the reason for the recall, and the potential risks to patients.
What is the purpose of class 2 device recall?
The purpose of class 2 device recall is to remove or correct medical devices that pose a moderate risk to patient safety.
What information must be reported on class 2 device recall?
The information reported on a class 2 device recall must include the device name, model number, reason for recall, risk to patients, and actions taken to address the issue.
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