Day

April 22, 2010
Company: Ge Healthcare ItcDate of Enforcement Report 4/21//2010 Class:ll PRODUCT 1) GE Centricity PACS-IW software; The intended use: The Centricity PACS-IW is used to receive medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations....
Read More
Company: Baxter Healthcare CorpDate of Enforcement Report 4/21//2010 Class:ll PRODUCT Baxter 1550 Single Patient System Hemodialysis Machines; product codes 5M5538, 5M5538R, 5M5575, 5M5551 and 5M5551R. Recall # Z-1322-2010 REASON Some of the 1550 Hemodialysis Instruments may have replacement circuit boards with incorrect versions of software.. RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Renal Div., Mc Gaw...
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.