The world's leading automated proofreading software

June 13, 2018

The Schlafender Hase Team

Medical Device Recalls

Packaging, Labeling and Software – The Human Machine Interface / HMI

The majority of medical device recalls are due to labeling or software – HMI issues. TVT can help keep you from becoming a statistic.

Q1 2018
  • Medical device recalls increased 126% this past quarter, more than double last quarter and the largest quarter since at least 2005.

  • 22.7% of recalls were for software, making it the top cause for the eighth consecutive quarter.

  • The average class I units recalled in Q1 2018 alone was 186,580,917. The average number of units recalled the entire year in 2017 was a fraction of this at 511,017.

Q4 2017
  • Medical device recalls declined 9%, the lowest quarter since Q4 2011,

  • However, 25.7% of recalls were for software, making it the top cause for the seventh consecutive quarter. The 2nd reason for recalls, at 23.7%, were due to a mislabeling issue.

Q3 2017
  • The average number of medical device units involved in Class I recalls was 876,076 per quarter in 2017, nearly triple the 310,158 average in 2016. The average was 276,233 in 2015.

Q2 2017
  • 47.3% of recalls were for software or mislabeling – the same top causes as the previous two quarters.

  • 53% of recalls were distributed both domestically and internationally, the highest percentage since Q1 2016.

Try TVT and see how worry-free the labeling and software creation can be for your next medical device project.

Do you want to find out more about how your proofreading life can be easier? Get in touch and we’ll tell you all about it.

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