Company: GE Healthcare, LLC
Date of Enforcement Report: 9/29/2021
Class II
PRODUCT
Centricity PACS-IW with Universal Viewer – Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.
Recall Number: Z-2502-2021
REASON
Image acquisition failures and synchronization failure with the Centricity Enterprise Archive.
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC on 8/6/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
392 (219 US; 173 OUS) all products
DISTRIBUTION
U.S. Nationwide and International