GE Healthcare, LLC recalls Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammo…

Recall date

October 11, 2018

Source

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

Recall number

Z-0374-2019

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

CA, CO, DE, FL, HI, NY, OK, PA, SD, TX, WA, WI, and WV Belgium, Brazil, Canada, Colombia, France, Germany, Ghana, Ireland, Italy, Mexico, Netherlands, Panama, Poland, Saudi Arabia, South Africa, Spain, Switzerland, and Turkey.

Why it was recalled

Synchronization failure

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.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources.