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Date: 05.02.2024 Olympus reference: QIL FY24EMEA36FY24OSTA06Soltive Laser System URGENT FIELD SAFETY NOTICE RE: OLYMPUS Soltive SuperPulsed Laser System Attention: Operation Room Director Material
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What is class 2 device recall?
A Class 2 device recall is a notification issued by manufacturers or the FDA regarding the removal or correction of devices that may cause temporary or medically reversible adverse health consequences.
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 when they identify a defect or hazardous condition.
How to fill out class 2 device recall?
To fill out a Class 2 device recall, one must complete the FDA's recall initiation form, detailing the product, the nature of the risk, and the corrective actions taken.
What is the purpose of class 2 device recall?
The purpose of a Class 2 device recall is to protect public health by preventing the use of medical devices that could cause temporary health issues or may not function as intended.
What information must be reported on class 2 device recall?
The information reported must include the device identification, recall classification, reason for recall, number of devices affected, and proposed corrective actions.
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