GE Healthcare recalls GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : The angiographic X-ray systems are indicated…

Recall date

December 10, 2014

Source

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

Recall number

Z-0966-2015

FDA classification

Class II

Brand / firm

GE Healthcare

Sold / distributed

Worldwide Distribution-Distributed in the states of CO, CT, MS, NJ, NY, OH, and WA, and the countries of BELGIUM, CANADA, CHINA, FRANCE, GERMANY, JAPAN, MEXICO, PERU, UNITED ARAB EMIRATES, and UNITED KINGDOM.

Why it was recalled

Potential unintentional system motion or rotation due to a positioning user interface issue with Discovery IGS 730 and 740 products.

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

What was recalled

GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular & non vascular diagnostic and interventional procedures. Discovery IGS 740: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and nonvascular, diagnostic and interventional procedures.