Company: GE Healthcare, LLC Date of Enforcement Report: 7/25/2022 Class II PRODUCT Centricity PACS Software Version 7.0 SP0.0.4.7 Recall Number: Z-1466-2022 REASON The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams. RECALLING FIRM/MANUFACTURER GE Healthcare, LLC VOLUME OF PRODUCT IN COMMERCE 47 installations...Read More
What are non-device software functions according to the FDA? The 21st century cures act excluded certain types of software. The term device, as defined in section 201(h), shall not include a software function that is intended— (A) for administrative support of a health care facility, including the processing and maintenance of financial records, claims or...Read More
Updated Risk Management training course now available. Includes:
Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
Why FMEA is incomplete for medical device risk management.