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URGENT MEDICAL DEVICE
Correctional of Letter Deployment GE Healthcare
3000 N. Grandview Blvd. W440
Waukesha, WI 53188 USAGE Ref# 30097To:Director of Biomedical Engineering
Chief of Nursing
Healthcare
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How to fill out urgent medical device correction
How to fill out urgent medical device correction
01
Identify the urgent medical device correction notice you have received.
02
Refer to the instructions provided in the notice for filling out the correction form.
03
Fill in all required fields accurately and completely.
04
Provide any additional information or documentation requested in the notice.
05
Submit the completed form according to the specified instructions.
Who needs urgent medical device correction?
01
Manufacturers of medical devices who have identified a potential issue with their product that poses a risk to patient safety.
02
Healthcare providers who have identified a potential issue with a medical device that they have distributed or used in patient care.
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What is urgent medical device correction?
Urgent medical device correction is a process to address and rectify serious safety issues with a medical device that pose 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 providing detailed information about the issue, affected devices, proposed correction actions, and timeline for implementation.
What is the purpose of urgent medical device correction?
The purpose of urgent medical device correction is to mitigate risks associated with a medical device and ensure the safety of patients and healthcare providers.
What information must be reported on urgent medical device correction?
The information reported on urgent medical device correction includes device identification, description of the issue, risk assessment, corrective actions, and contact information.
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