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September 3, 2015Field Safety Notice Urgent Medical Device Correction 295584208/08/15008C da Vinci Si Single Site Grip Release Dear da Vinci Customer, The purpose of this Field Safety Notification
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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 notification received from the manufacturer.
02
Review the instructions and guidance provided in the notification.
03
Contact the manufacturer or authorized representative for additional information or assistance if needed.
04
Follow the specified steps for filling out the required forms or documents accurately.
05
Submit the completed urgent medical device correction notification to the manufacturer or authorized representative as instructed.
Who needs urgent medical device correction?
01
Patients who have been implanted with the specific medical device that requires urgent correction.
02
Healthcare professionals who have prescribed or used the medical device on patients.
03
Medical facilities or institutions where the medical device is being used.
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What is urgent medical device correction?
Urgent medical device correction is a corrective action taken by a manufacturer to address an urgent safety issue related to their medical device.
Who is required to file urgent medical device correction?
Manufacturers of medical devices are required to file urgent medical device correction.
How to fill out urgent medical device correction?
Urgent medical device correction forms can be filled out electronically or submitted in writing to the appropriate regulatory authority.
What is the purpose of urgent medical device correction?
The purpose of urgent medical device correction is to address safety issues with medical devices and protect patients.
What information must be reported on urgent medical device correction?
Information such as the reason for the correction, affected product details, corrective actions taken, and contact information must be reported on urgent medical device correction.
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