Day

July 10, 2024
10
Jul

FDA Recall: Software Bug Can Cause Inaccurate Measurements

July 10, 2024
Company: Echonous Inc. Date of Enforcement Report: 7/10/2024 Class II PRODUCT Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system. Recall Number: Z-2325-2024 REASON: Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd...
Read More
10
Jul

FDA Recall: Software Bug Causing Inaccuracy in Measurements

July 10, 2024
Company: Echonous Inc. Date of Enforcement Report: 7/10/2024 Class II PRODUCT Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system. Recall Number: Z-2325-2024 REASON: Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd...
Read More

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
office@softwarecpr.com
Partners located in the US (CA, FL, MA, MN, TX) and Canada.