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URGENT MEDICAL DEVICE Correctional of Letter Deployment GE Healthcare 3000 N. Grandview Blvd. W440 Waukesha, WI 53188 USAGE Ref# 36149To:Director of Biomedical / Clinical Engineering Chief of Nursing
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What is urgent medical device?
Urgent medical device is a medical device that poses a serious risk to public health and safety.
Who is required to file urgent medical device?
Manufacturers, importers, and distributors of medical devices are required to file urgent medical device.
How to fill out urgent medical device?
Urgent medical device can be filled out by providing detailed information about the device, including the risk it poses and the actions taken to address it.
What is the purpose of urgent medical device?
The purpose of filing urgent medical device is to ensure that appropriate actions are taken to mitigate the risks associated with the device.
What information must be reported on urgent medical device?
Information such as the identification of the device, the nature of the risk it poses, and the actions taken to address the risk must be reported on urgent medical device.
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