Hitachi Healthcare Americas Corporation recalls ECHELON Oval MRI System

Recall date

July 29, 2021

Source

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

Recall number

Z-2338-2021

FDA classification

Class II

Brand / firm

Hitachi Healthcare Americas Corporation

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Mexico and Brazil.

Why it was recalled

There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437.

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

What was recalled

ECHELON Oval MRI System