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This document serves to inform users about a potential issue with the ExacTrac 6.0 patient positioning system, specifically regarding the monoscopic Intra-Fraction Snap Verification which may display
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How to fill out FIELD SAFETY NOTICE / PRODUCT NOTIFICATION
01
Start with the header that clearly states 'Field Safety Notice / Product Notification'.
02
Include the date of the notice.
03
Provide a brief description of the product and its intended use.
04
Outline the reason for the notification, detailing any safety concerns.
05
Specify the affected product models, lot numbers, or serial numbers.
06
Include instructions for the recipients on what actions they need to take.
07
Provide contact information for questions or further support.
08
Clearly state the deadline for responding to the notice.
Who needs FIELD SAFETY NOTICE / PRODUCT NOTIFICATION?
01
Customers who have purchased the affected product.
02
Healthcare professionals using the product.
03
Distributors and retailers who sell the product.
04
Regulatory authorities that oversee product safety.
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People Also Ask about
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.
What is SFR in medical terms?
Spotted fever rickettsioses (SFR) are nationally notifiable diseases caused by spotted fever group Rickettsia.
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 medical FSN?
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.
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.
What is a field corrective action medical device?
A Field Safety Corrective Action is an action taken by a manufacturer to report any technical or medical reason leading to a systematic recall of devices of the same type by the manufacturer to the National Competent Authority.
What is FSN in healthcare?
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.
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.
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What is FIELD SAFETY NOTICE / PRODUCT NOTIFICATION?
A Field Safety Notice / Product Notification is a formal communication issued by manufacturers to inform customers and users about safety issues or potential product risks associated with medical devices or products.
Who is required to file FIELD SAFETY NOTICE / PRODUCT NOTIFICATION?
Manufacturers, distributors, and importers of medical devices or products are required to file a Field Safety Notice / Product Notification whenever a safety issue or product risk is identified.
How to fill out FIELD SAFETY NOTICE / PRODUCT NOTIFICATION?
To fill out a Field Safety Notice, you must provide specific details including the product identification, nature of the issue, potential risks, corrective actions, and instructions for users and customers on how to proceed.
What is the purpose of FIELD SAFETY NOTICE / PRODUCT NOTIFICATION?
The purpose of a Field Safety Notice / Product Notification is to ensure the safety of patients and users by promptly informing them about identified hazards or product defects and guiding them on necessary actions.
What information must be reported on FIELD SAFETY NOTICE / PRODUCT NOTIFICATION?
The information that must be reported includes product details (name, model, serial number), description of the safety issue, identified risks, instructions for corrective action, and contact information for further assistance.
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