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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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Identify the urgent medical device correction notice you have received.
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Who needs urgent medical device correction?

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Manufacturers of medical devices who have identified a potential issue with their product that poses a risk to patient safety.
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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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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.
Manufacturers, distributors, and importers of medical devices are required to file 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.
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.
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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