Day

May 24, 2024
24
May

FDA Recall: Software Upgrade Issue Leading to Table Pivot Brake Not Engaging

May 24, 2024
Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Date of Enforcement Report: 5/24/2024 Class II PRODUCT Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100. Recall Number: Z-1895-2024 REASON: When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does...
Read More

SoftwareCPR Training Courses

ISO13485:2016 ISO 13485 Internal Audit(or) Training Course (Live, 3-day)

IEC 62304 and other Emerging Standards Impacting Medical Device Software (Live, 3-day)

Being Agile & Yet CompliantISO 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.