Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources.

FDA Recall Z-0375-2019 · Posted None

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeLLZ
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.

↑