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January 19, 2018 FSN86100187AMedical Device Recall / Labeling Correction Philips HeartStart MRx and FR3 Monitor/Defibrillator And HeartStart FR3 AED Used With QCPR Meter or CPR SensorDear HeartStart
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What is urgent - medical device?
An urgent medical device refers to a medical product that requires immediate corrective actions due to safety or health concerns, typically after identifying a flaw or potential harm to patients.
Who is required to file urgent - medical device?
Manufacturers, importers, and sometimes healthcare providers are required to file reports regarding urgent medical devices to regulatory authorities.
How to fill out urgent - medical device?
To fill out an urgent medical device report, gather all relevant information about the device, the issue, affected patients, and actions taken, and complete the required forms from the relevant regulatory agency.
What is the purpose of urgent - medical device?
The purpose of an urgent medical device report is to alert regulators and the public about safety issues, prompting swift action to mitigate risks associated with the device.
What information must be reported on urgent - medical device?
Information that must be reported includes device identification, nature of the issue, risk assessment, corrective actions taken, and any adverse events associated with the device.
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