Company: GE Healthcare
Date of Enforcement Report 6/13/2018
Class II:
PRODUCT
Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Recall Number: 1) Z-2101-2018 2) Z-2012-2018
REASON
Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer..
RECALLING FIRM/MANUFACTURER
GE Healthcare, chicago, IL Bergen Norway on 1/25/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1) 44 2) 252
DISTRIBUTION
Nationwide and Internationally