GE Healthcare, LLC recalls Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for a…

Recall date

March 29, 2019

Source

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

Recall number

Z-1753-2019

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

Worldwide Distribution: US (nationwide) to states of: AL, CA, CT, FL, GA, HI, IL, LA, MD, MI, MN, MO, NH, NY, OK, PA, TN, and VA; and countries of: Algeria, Argentina, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Canada, China, Costa Rica, Cote D'Ivoire, Cyprus, Czech Republic, Egypt , France,…

Why it was recalled

There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.

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

What was recalled

Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general radiology applications with or without contract injection and interventional procedures.