Day

February 8, 2024
08
Feb

FDA Recall: Software Issue Incorrectly Labeled Captured Images

February 8, 2024
Company: PHILIPS MEDICAL SYSTEMS Date of Enforcement Report: 2/8/2024 Class II PRODUCT Spectral CT on Rails: Software Version 5.1.0.X, model 728334 Recall Number: Z-1054-2024 REASON: A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment. RECALLING FIRM/MANUFACTURER: PHILIPS MEDICAL SYSTEMS VOLUME OF PRODUCT IN COMMERCE: US:...
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.