GE Healthcare, LLC recalls Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human an…

Recall date

March 15, 2019

Source

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

Recall number

Z-1199-2019

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

Nationwide distribution to AR, CA, CA, FL, MI, NM, NV, SC, TN, TX, VA, WA, WI. International distribution to Algeria, Belgium, China, Colombia, France, Hungary, Italy, Japan, Korea (Republic Of), Kuwait, Libya, Pakistan, Poland, Russia, Saudi Arabia, South Africa, Sudan, Turkey, Vietnam.

Why it was recalled

There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously.

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

What was recalled

Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.