GE Healthcare recalls The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data f…

Recall date

September 28, 2015

Source

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

Recall number

Z-0225-2016

FDA classification

Class II

Brand / firm

GE Healthcare

Sold / distributed

Worldwide Distribution-US (nationwide) including the states of AZ, CA, CO, DE, FL, GA, IA, IL, IN, LA, MA, MI, MN, MO, NJ, NY, OR, PA, SC, SD, TN, TX, VA, WA, WI and WV, and the countries of Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Ecuador, France, Germany, Ghana, Hong…

Why it was recalled

Inaccurate distance measurements with magnified projection X-ray images.

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

What was recalled

The 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. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.