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This document serves as an urgent safety notice informing users about software programming errors in the Biometer Lenstar LS 900 related to patient record linking and calculation results.
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How to fill out urgent field safety notice
How to fill out Urgent Field Safety Notice 2011 - 02/01
01
Obtain a copy of the Urgent Field Safety Notice 2011 - 02/01.
02
Review the notice carefully to understand the specific instruction and recommendations.
03
Identify the recipients that need to be informed.
04
Fill in the required information in the notice, including details of the affected devices.
05
Specify the actions that need to be taken by the recipients.
06
Include the deadline for actions and the contact information for further assistance.
07
Distribute the notice to all relevant stakeholders, including healthcare providers and facilities using the affected devices.
08
Keep a record of all communications related to this notice.
Who needs Urgent Field Safety Notice 2011 - 02/01?
01
Healthcare providers who use the affected devices.
02
Medical facilities that have received the devices.
03
Patients who may be impacted by the safety notice.
04
Regulatory bodies monitoring medical device safety.
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People Also Ask about
What is a FSCA in medical devices?
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 an IVD that is already placed on the market.
What is a field safety notice?
Field Safety Notice. A communication sent out by a manufacturer or its representative to the device users in relation to a Field Safety Corrective Action.
What is the resmed field safety notice?
The update to the warning includes the safe distance to the magnets has been increased from 2 inches (50 mm), and patients are now warned to keep the mask magnets at a safe distance of 6 inches (150 mm) away from implants or medical devices that may be adversely impacted by magnetic interference.
What is a field safety notice?
Field Safety Notice. A communication sent out by a manufacturer or its representative to the device users in relation to a Field Safety Corrective Action.
What is a field action notice?
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 field safety?
Development of field safety plans is critical for identifying and mitigating risk in the field. These plans allow you to prepare for situations you may encounter and know how to respond. The purpose of the plan is to make sure all staff and students are not caught unprepared and are aware of hazards they may encounter.
What is an example of a field safety corrective action?
The FSCA may include; the return of a medical device to the supplier, device modification, device exchange, device destruction, retrofit by purchaser of manufacturer's modification or design change, advice given by manufacturer regarding the use of the device (e.g. where the device is no longer on the market or has
What is a field safety notification?
A communication to customers and/or users sent out by a manufacturer or its representative in relation to a Field Safety Corrective Action.
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What is Urgent Field Safety Notice 2011 - 02/01?
Urgent Field Safety Notice 2011 - 02/01 is a communication issued to inform healthcare professionals and users about safety issues related to a specific medical device or product that may pose a risk to patient safety.
Who is required to file Urgent Field Safety Notice 2011 - 02/01?
Manufacturers or distributors of the medical device or product in question are required to file Urgent Field Safety Notice 2011 - 02/01.
How to fill out Urgent Field Safety Notice 2011 - 02/01?
To fill out Urgent Field Safety Notice 2011 - 02/01, one must provide specific details about the safety issue, including the product affected, the nature of the risk, recommended actions for users, and contact information for further inquiries.
What is the purpose of Urgent Field Safety Notice 2011 - 02/01?
The purpose of Urgent Field Safety Notice 2011 - 02/01 is to ensure that all relevant stakeholders are made aware of urgent safety information regarding a medical device and to mitigate potential risks to patients.
What information must be reported on Urgent Field Safety Notice 2011 - 02/01?
The Urgent Field Safety Notice 2011 - 02/01 must report information such as the product name, model/serial numbers, description of the safety issue, health risks involved, corrective actions to be taken, and contact information for the issuing authority.
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