Hitachi Medical Systems America Inc recalls Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087

Recall date

June 30, 2015

Source

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

Recall number

Z-2392-2016

FDA classification

Class II

Brand / firm

Hitachi Medical Systems America Inc

Sold / distributed

US Distribution to the states of : CA, FL, GA, IA, IL, IN, MD, NC, NY, OH, PA, SD, TN, TX & WY., and Internationally to Brazil and Mexico.

Why it was recalled

The firm discovered that the centrifugal force applied to the power supply may cause it to fail over time. The exam performed at the time of the failure will likely be lost, resulting in the need to rescan the patient.

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 Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087