GE Healthcare, LLC recalls AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696, a receive-only RF coil designe…

Recall date

March 19, 2019

Source

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

Recall number

Z-0062-2020

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

Worldwide Distribution - US Nationwide in the states of AZ, CA, MS, NY, WI, DE, and countries of France, Germany, Japan, Netherlands, Spain, Sweden,

Why it was recalled

The outer seam of the coil, closest to the system cable, may separate and expose the porous material internal to the coil. This could result in user and/or patient contact with infectious agents since the internal porous material cannot be disinfected.

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

What was recalled

AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696, a receive-only RF coil designed for use with GE 3.0T MRI systems.