Hitachi Medical Systems America Inc recalls Hitachi Scenaria Whole-body X-ray CT System

Recall date

October 16, 2019

Source

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

Recall number

Z-0271-2020

FDA classification

Class II

Brand / firm

Hitachi Medical Systems America Inc

Sold / distributed

The devices were distributed to the following US states: CA, FL, GA, IA, IN, MD, MT, NC, NY, OH, OK, SD, TN, TX, WY, and PR. The products were distributed to the following foreign countries: Brazil and Mexico.

Why it was recalled

There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system.

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

What was recalled

Hitachi Scenaria Whole-body X-ray CT System