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This document informs health care professionals about a field safety notice regarding the AVOXimeter 1000 and AVOXimeter 1000E instruments, highlighting potential issues with 'diagnostic mode' that
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How to fill out field safety notice
How to fill out Field Safety Notice - ITC No. 08-003
01
Gather all relevant information about the device affected by the Field Safety Notice.
02
Review the details of ITC No. 08-003 to understand the specific safety concerns.
03
Clearly write the date and reference number at the top of the notice.
04
Provide a description of the issue and potential risks associated with the device.
05
Outline the actions that need to be taken by the recipients.
06
Include contact information for further inquiries or reporting.
07
Distribute the notice to all healthcare providers, institutions, and patients affected.
08
Document the distribution process for records and follow-up.
Who needs Field Safety Notice - ITC No. 08-003?
01
Healthcare providers who use the affected device.
02
Medical institutions where the device is utilized.
03
Patients who may be impacted by the safety concerns.
04
Regulatory agencies overseeing medical device safety.
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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 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 are field safety notices?
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 an example of a field safety corrective action?
Definition of Field Safety Corrective Action (FSCA) An FSCA may include, for example: returning the device to the distributor, modifying or replacing the device, or other actions taken by the manufacturer.
What is a field safety corrective action?
A field safety corrective action (FSCA) is an action taken by a manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device.
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 - ITC No. 08-003?
Field Safety Notice - ITC No. 08-003 is a formal communication issued to inform stakeholders about potential safety issues related to a specific product, detailing necessary actions to mitigate risks.
Who is required to file Field Safety Notice - ITC No. 08-003?
Manufacturers, importers, and distributors of the affected product are required to file Field Safety Notice - ITC No. 08-003.
How to fill out Field Safety Notice - ITC No. 08-003?
To fill out Field Safety Notice - ITC No. 08-003, users should include specific details about the product, the nature of the safety issue, corrective actions required, and the timeline for completing these actions.
What is the purpose of Field Safety Notice - ITC No. 08-003?
The purpose of Field Safety Notice - ITC No. 08-003 is to ensure safety by informing all impacted parties about risks associated with the product and guiding them on how to address these concerns.
What information must be reported on Field Safety Notice - ITC No. 08-003?
Information that must be reported includes the product identification, description of the safety issue, potential risks, recommended actions for users, and contact details for further inquiries.
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