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URGENT: MEDICAL DEVICE RECALL/EXCHANGE 2nd Generation noble LED Phototherapy Lights March 2017 Dear Valued Customer: You are receiving this information as our records indicate you may have one or
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Urgent medical device recall/exchange is a process where medical devices that pose a health risk or are defective are removed from the market or exchanged for a safe alternative.
Manufacturers, importers, and distributors of medical devices are required to file urgent medical device recall/exchange.
To fill out urgent medical device recall/exchange, the manufacturer must provide details about the device, the reason for the recall/exchange, and instructions for customers.
The purpose of urgent medical device recall/exchange is to protect the public from potentially harmful or defective medical devices.
Information that must be reported includes the name and description of the device, the reason for the recall/exchange, the health risk posed, and the proposed remedy.
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