Company: GE Healthcare, LLC
Date of Enforcement Report: 11/2/2018
Class II:
PRODUCT
Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources.
Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources.
Recall Number: Z-0374-2019 (5.0.x), Z-0375-2019 (6.0.x)
REASON
Synchronization failure
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI on 10/11/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
13 (5.0.x), 73 (6.0.x)
DISTRIBUTION
Nationwide and International
You can find all recent FDA Enforcement Reports on the FDA.gov website: www.accessdata.fda.gov