FDA Software Recall Summary – 2017

Based on our searches and posting of software related recalls there appears to be a significant decrease of recalls reported to FDA in 2017 compared to 2016. Yearly total software recalls to the best of our ability to identify were for the past year are listed below. For previous years, search our library or look in the recall section for the complete historical summary back to 2004.

2017:  176
2016:  346
2015:  256
2014:  228

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.