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SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems T
Recalled November 19, 2025 · FDA recall Z-0499-2026 · SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Hazard
Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft. · FDA Class II
Units
1,766 devices
Sold at
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SM, SC, SD, TN, TX, VA, WA, and WI. The countries of Dominica, Grand Bahama, Haiti, and Saint Maarten.
Description
Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft.
Product
Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and collimator to position the X-ray tube unit. This unit is used for radiographic examinations of whole body except mammography when combined with an X-ray high voltage generator, an X-ray tube unit, an X-ray collimator, and if necessary, an X-ray radiography stand, an X-ray radiography table, and digital radiography system.
Manufacturer(s)
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Made in
Japan
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →