Centricity PACS Software Version 7.0 SP0.0.4.7
- Company
- Ge Healthcare, Llc
- Recall Initiated
- June 14, 2022
- Terminated
- January 16, 2024
- Recall Number
- Z-1466-2022
- Quantity
- 47 installations
- Firm Location
- Waukesha, WI
Reason for Recall
The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
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.
Lot / Code Info
Model: 5831882-012, Software Version 7.0 SP0.0.4.7 GTIN: 00840682145572
Root Cause
Software design
Action Taken
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.