Recall Z-1466-2022 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
Centricity PACS Software Version 7.0 SP0.0.4.7
| Date | Jun 14, 2022 |
| Status | Terminated |
| Reason | The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams. |
| Root cause | Software design |
| Action | 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, Direc |
| Quantity | 47 installations |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of CO, NV, OH, PA, WA and the countries of Brazil, Canada, China, France, Germany, Israel, Italy, Japan, Oman, Spain, Switzerland, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110875 | CENTRICITY PACS GE Healthcare, May 5, 2011 |