FDA-Device2017-07-05Class II

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

Shimadzu Medical Systems Usa Com
Hazard

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

Sold states
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
Affected count
1673 units total
Manufactured in
20101 S Vermont Ave, N/A, Torrance, CA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2653-2017

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