Shimadzu Medical Systems Usa Com recalls SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-200/CH-200M Holds an x-ray tube unit and col…

Recall date

May 23, 2017

Source

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

Recall number

Z-2653-2017

FDA classification

Class II

Brand / firm

Shimadzu Medical Systems Usa Com

Sold / distributed

Worldwide Distribution - Nationwide distribution to AK, AR, AZ, CA, CT, FL, IL, IN, KS, LA, MI, MO, NE, NJ, NM, NV, NY,OH, OK, PA, RI, SC, TN, TX, WA, WI, and Hawaii Foreign: Canada and Japan

Why it was recalled

Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.

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

What was recalled

SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-200/CH-200M Holds an x-ray tube unit and collimator combined with an z-ray high voltage generator, radiographic stand, and table. It is designed to perform radiography of patients either in a standing or supine position