FDA Data Reveals Medical Device Recalls Software Woes

According to the U.S. Food and Drug Administration records, in an average year over 2,500 medical device recalls are issued in the United States. Some of these recalls simply require checking the device for problems, but others require the return or destruction of the device. Once identified, the FDA categorizes the root cause of these recalls into 40 categories, plus a catchall of “other”: situations that include labeling mix-ups, problems with expiration dates, and counterfeiting.

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