GE Healthcare recalls The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop…

Recall date

November 12, 2014

Source

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

Recall number

Z-0955-2015

FDA classification

Class II

Brand / firm

GE Healthcare

Sold / distributed

US Distribution to the states of CA, FL, IL, NY, UT and WA.

Why it was recalled

A required quality control test was not performed during installation associated with the software of the Revolution CT scanner.

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

What was recalled

The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.