GE Healthcare recalls GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.

Recall date

December 19, 2014

Source

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

Recall number

Z-0985-2015

FDA classification

Class II

Brand / firm

GE Healthcare

Sold / distributed

US: FL, WA, IL, UT, NY, CA. OUS: Canada, France, Hong Kong, Japan, Switzerland, United Arab Emirates.

Why it was recalled

Potential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. No injuries or illnesses reported.

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 Revolution CT., multi-slice (256 detector row) CT scanner.