Day

May 16, 2025
16
May

FDA Recall: Import of enhanced ultrasound formatted data can result in incorrect display of image orientation

May 16, 2025
Company: Echopixel, Inc. Date of Enforcement Report: 5/16/2025 Class II PRODUCT True 3D Viewer, Model: EP-00003 Recall Number: Z-1785-2025 REASON: With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image processing/review/analysis/communication/media interchange acquired from CT/MRI/ultrasound, and pre-operative analysis of surgical options), can result in incorrect display of image...
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.