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This document notifies users about a potential incorrect dose calculation when using iPlan RT Dose version 4.0 or 4.1 after modifications of MLC shapes. It provides corrective actions and information

How to fill out field safety notice product

How to fill out FIELD SAFETY NOTICE / PRODUCT NOTIFICATION

1. Begin with the title 'Field Safety Notice / Product Notification'.
2. Include the date of the notification.
3. Provide product identification details, including product name, model numbers, and batch/serial numbers.
4. Describe the issue or safety concern in clear and concise terms.
5. Provide instructions for recipients on what actions to take (e.g., stop using the product, return the product, etc.).
6. Include contact information for further assistance or questions.
7. Specify the timeframe for compliance with the notice.
8. Confirm the notice is signed by an authorized individual.

Who needs FIELD SAFETY NOTICE / PRODUCT NOTIFICATION?

1. Healthcare providers who may have used the product.
2. Distributors and retailers who have sold the product.
3. Patients or users who have the product in their possession.
4. Regulatory authorities that need to be informed of the safety issue.

People Also Ask about

What is a field safety notification?

A field safety notice (FSN) is an important means of communicating a field safety corrective action (FSCA) and related safety information to users. It may also be used to provide updated information about how an IVD should be used.

What is a safety recall notice?

In the safety recall notice, the manufacturer will explain to the owner any potential safety hazards posed by the defect. The notice will also tell you what to do about it.

What is FSN in medical terms?

Field safety notices (FSNs): are safety communications sent out by medical device manufacturers or their representatives in relation to actions that may be taken in relation to their Medical Device that is on the market.

Is a field safety notice a recall?

Recall: it is a type of FSN where a manufacturer takes a correction or removal action to address a problem with a medical device, Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

What qualifies as a recall?

Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective.

What is a field safety notice?

A 'field safety notice' (FSN) is an important communication about the safety of a medical device that is sent to customers by a device manufacturer, or their representative. FSNs tell you what you need to do to reduce the specified risks of using the medical device.

For pdfFiller’s FAQs

What is FIELD SAFETY NOTICE / PRODUCT NOTIFICATION?

A Field Safety Notice (FSN) or Product Notification is a communication issued by a manufacturer to inform users about potential safety issues associated with a specific medical device or product, detailing risks, corrective actions, and recommendations.

Who is required to file FIELD SAFETY NOTICE / PRODUCT NOTIFICATION?

Manufacturers or authorized representatives of medical devices or products are required to file a Field Safety Notice or Product Notification when they identify a safety issue that may affect users or patients.

How to fill out FIELD SAFETY NOTICE / PRODUCT NOTIFICATION?

To fill out a Field Safety Notice, one should provide clear and concise information including a description of the product, the nature of the safety issue, the specific risks involved, and recommended actions for users.

What is the purpose of FIELD SAFETY NOTICE / PRODUCT NOTIFICATION?

The purpose of a Field Safety Notice or Product Notification is to protect patient safety by informing users of potential risks associated with a product, ensuring they take necessary precautions or actions.

What information must be reported on FIELD SAFETY NOTICE / PRODUCT NOTIFICATION?

Information that must be reported includes product identification details, description of the safety issue, the risks involved, corrective actions to be taken, and contact information for further inquiries.