Company: GE Healthcare, LLC
Date of Enforcement Report: 6/19/2019
Class II
PRODUCT
GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x
Recall Number: Z-1781-2019
REASON
There is a potential that one or more image series (i.e., all images within an image set) may be missing from an exam without a warning displayed in the viewer.
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC on 6/19/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
620 units
DISTRIBUTION
US Nationwide and International