GE Healthcare recalls Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammo…

Recall date

September 16, 2015

Source

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

Recall number

Z-0023-2016

FDA classification

Class II

Brand / firm

GE Healthcare

Sold / distributed

Worldwide Distribution: US (nationwide) including states of: AL AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, ON, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico; and countries of: Argentin…

Why it was recalled

Images may be missing when a system parameter MapRoute is set to a value greater than 1.

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 by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.