Recall StatusTerminated
Date Initiated2018-10-11
Date Terminated2023-03-20
Product Quantity73
Reason for Recall
Synchronization failure
Firm Action
On October 12, 2018 GE Healthcare send recall notification to all their consignees with the following instructions;
If you do not use a Diagnostic viewer (e.g. Centricity Universal Viewer Zero Footprint Client or any 3rd party dicom viewer) connected directly to the same Centricity EA to display images for diagnostic purposes, your system is not affected by the safety issue.
If you do use a Diagnostic viewer (e.g. Centricity Universal Viewer Zero Footprint Client or any 3rd party dicom viewer) connected directly to the same Centricity EA to display images for diagnostic purposes, please contact GE Healthcare service representative immediately. GE Healthcare will assist you in determining if your system is affected and, if necessary, will assist you with a solution to confirm that study updates are made in the Enterprise Archive, until GE Healthcare can install a correction on your system.
GE Healthcare will provide a correction that will be installed by a GE service engineer. A GE Healthcare representative will contact you to arrange for the correction. This activity will be performed at no cost to you.
Contact Information
If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Root Cause
Software design
Distribution Pattern
CA, CO, DE, FL, HI, NY, OK, PA, SD, TX, WA, WI, and WV
Belgium, Brazil, Canada, Colombia, France, Germany, Ghana, Ireland, Italy, Mexico, Netherlands, Panama, Poland, Saudi Arabia, South Africa, Spain, Switzerland, and Turkey.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.