GE Healthcare, LLC recalls Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal View…

Recall date

May 17, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1885-2019

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

Worldwide Distribution - US Nationwide Austria, Belgium, Brazil Canada Colombia France Germany Ghana India Ireland Israel Italy Kuwait Mexico Netherlands Panama Poland Qatar Russia Saudi Arabia Slovenia South Africa Spain Switzerland Turkey United Arab Emirates United Kingdom Uruguay

Why it was recalled

There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of this system are authorized healthcare professionals. Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information. Mammography images may only be interpreted using a monitor compliant with requirements of local regulations and must meet other technical specifications reviewed and accepted by the local regulatory agencies. Contraindications: Centricity Universal Viewer is contraindicated for the use of lossy compressed mammographic images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.