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URGENT FIELD SAFETY NOTICELiion battery packs used in BIS Vista and BIS View Monitoring Systems. August XX, 2018Medtronic reference: FA832 Attention: OR Materials Management, Risk Management, Biomedical
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How to fill out urgent field safety notice

01
Start by collecting all relevant information about the safety issue.
02
Determine the affected products and their serial numbers.
03
Draft a clear and concise notice detailing the safety concern and its potential impact.
04
Include instructions on how to identify the affected products and what actions need to be taken.
05
Distribute the notice to all relevant stakeholders, including customers, distributors, and regulatory authorities.
06
Monitor responses and follow-up actions to ensure effective communication and resolution.

Who needs urgent field safety notice?

01
Manufacturers of products with safety issues
02
Distributors and retailers selling the affected products
03
Customers who have purchased the affected products
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Urgent field safety notice is a communication issued by medical device manufacturers to inform users of a device of a potential risk related to the device.
Medical device manufacturers are required to file urgent field safety notices.
Urgent field safety notices can typically be filled out online through the regulatory authority's portal, providing details about the device, the issue, and any corrective actions.
The purpose of urgent field safety notice is to alert users of a medical device about potential risks associated with the device and to provide instructions for mitigating those risks.
Information that must be reported on urgent field safety notices includes details about the device, the identified issue, potential hazards, and recommended corrective actions.
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