GE Healthcare, LLC Centricity PACS Software Version 7.0 SP0.0.4.7 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.

Recommended Action

Per FDA guidance

An Urgent Medical Device Correction letter was sent to customers beginning June 14, 2022. The letter informs the customer of the issue and provides safety instructions for continued use of the device. GE Healthcare will correct all affected devices via a software update. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director/Manager of Radiology, Director/Manager of Cardiology, Risk Manager/Hospital Administrator, Head of Radiology Department, Head of Cardiology Department, PACS Administrator, Director of IT Department, Head of Biomedical Engineering, Head of Imaging Informatics.