GE Medical Systems, LLC recalls GE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray systems are indicated for use for patients from new…

Recall date

November 13, 2015

Source

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

Recall number

Z-0414-2016

FDA classification

Class II

Brand / firm

GE Medical Systems, LLC

Sold / distributed

Worldwide Distribution - US Nationwide in the states of: AR, AZ, DC, FL, GA, IL, IN, LA, MI, NC, NE, NJ, NV, NY, OH, SC, TN, TX, WA. and the countries of Algeria, Bangladesh, Bosnia and Herzegovina, Brazil, China, Dominican Republic, Ethiopia, Georgia, Germany, India, Indonesia, Italy, Lebanon Mart…

Why it was recalled

GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems.

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 Optima IGS 320. Product Usage: 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 non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures.