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GE Healthcare URGENT FIELD SAFETY NOTICE Date of Letter Deployment3000 N. Grandview Blvd. W440 Waukesha, WI 53188, USAGE Ref# 12283To: Director of Breast Imaging Director of Radiology Director of
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How to fill out urgent medical device correction
How to fill out urgent medical device correction
01
Identify the specific information needed for the urgent medical device correction.
02
Complete all required forms and documents accurately.
03
Submit the necessary information to the appropriate regulatory agency.
04
Follow up with the regulatory agency to ensure the correction is processed in a timely manner.
Who needs urgent medical device correction?
01
Companies or manufacturers who have identified a safety issue with their medical device that requires immediate action.
02
Regulatory agencies responsible for overseeing medical device safety and efficacy.
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What is urgent medical device correction?
Urgent medical device correction is a process where immediate action is required to correct an issue with a medical device that poses a risk to public health.
Who is required to file urgent medical device correction?
Manufacturers, distributors, and importers of medical devices are required to file urgent medical device correction.
How to fill out urgent medical device correction?
Urgent medical device correction can be filled out by submitting a report to the relevant regulatory authorities detailing the issue and proposed corrective actions.
What is the purpose of urgent medical device correction?
The purpose of urgent medical device correction is to ensure the safety and effectiveness of medical devices in the market and to protect public health.
What information must be reported on urgent medical device correction?
Information such as the description of the issue, affected product details, potential risks, proposed corrective actions, and expected completion timeline must be reported on urgent medical device correction.
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