Medical device recalls Moderate risk

GE Healthcare, LLC recalls Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from…

Recall date
October 11, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0375-2019
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 Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources.

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