Day

July 14, 2021
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 7/14/2021 Class II PRODUCT ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000 Recall Number: Z-2029-2021 REASON Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging...
Read More
Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 7/14/2021 Class II PRODUCT The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes. Tests performed using this system are intended for...
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
Partners located in the US (CA, FL, MA, MN, TX) and Canada.