SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls Ceiling Type X-Ray Tube Support

Recalling company

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

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.

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Oct 16, 2025

Reported

Nov 19, 2025

Distribution

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.

Status

Ongoing

Quantity

1,766 devices

Lot / codes

Model Numbers: CH-200. UDI code: 04540217014484. Serial Numbers: 3ZC5C2A84014, 3ZC5C2A85003, 3ZC5C2A77013, 3ZC5C2A86013, 3ZC5C2A75012, 3ZC5C2A76002, 3ZC5C2A76016, 3ZC5C2A76026, 3ZC5C2A79003, 3ZC5C2A84008, 3ZC5C2A73001, 3ZC5C2A87008, 3ZC5C2A7A001, 3ZC5C2A76018, 3ZC5C2A79001, 3ZC5C2A7A002, 3ZC5C2A7B001, 3ZC5C2A85015, 3ZC5C2A81001, 3ZC5C2A86003, 3ZC5C2A7C007, 3ZC5C2A84002, 3ZC5C2A7B019, 3ZC5C2A77010, 3ZC5C2A73006, 3ZC5C2A74004, 3ZC5C2A75002, 3ZC5C2A75005, 3ZC5C2A75006, 3ZC5C2A75007, 3ZC5C2A76010, 3ZC5C2A76013, 3ZC5C2A76022, 3ZC5C2A77011, 3ZC5C2A77012, 3ZC5C2A77014, 3ZC5C2A77023, 3ZC5C2A78002, 3ZC5C2A78003, 3ZC5C2A79002, 3ZC5C2A7C006, 3ZC5C2A7C016, 3ZC5C2A82004, 3ZC5C2A83002, 3ZC5C2A85010, 3ZC5C2A85016, 3ZC5C2A85018, 3ZC5C2A86002, 3ZC5C2A86009, 3ZC5C2A86011, 3ZC5C2A87010, 3ZC5C2A88003, 3ZC5C2A88005, 3ZC5C2A81002, 3ZC5C2A85017, 3ZC5C2A7B002, 3ZC5C2A86004, 3ZC5C2A85005, 3ZC5C2A71003, 3ZC5C2A86010, 3ZC5C2A81004, 3ZC5C2A73012, 3ZC5C2A73013, 3ZC5C2A73014, 3ZC5C2A76006, 3ZC5C2A76019, 3ZC5C2A76027, 3ZC5C2A77003, 3ZC5C2A7B015, 3ZC5C2A85019, 3ZC5C2A88008, 3ZC5C2A77002, 3ZC5C2A85002, 3ZC5C2A85001, 3ZC5C2A74005, 3ZC5C2A72005, 3ZC5C2A73002, 3ZC5C2A73009, 3ZC5C2A73010, 3ZC5C2A74007, 3ZC5C2A76008, 3ZC5C2A76009, 3ZC5C2A76017, 3ZC5C2A77001, 3ZC5C2A77009, 3ZC5C2A77017, 3ZC5C2A78005, 3ZC5C2A78006, 3ZC5C2A79007, 3ZC5C2A7B008, 3ZC5C2A7B011, 3ZC5C2A7B016, 3ZC5C2A7C014, 3ZC5C2A7C017, 3ZC5C2A81005, 3ZC5C2A81006, 3ZC5C2A81014, 3ZC5C2A84009, 3ZC5C2A85011, 3ZC5C2A85013, 3ZC5C2A75008, 3ZC5C2A85009, 3ZC5C2A

Company location

Kyoto

Recall type

Voluntary: Firm initiated

Recall number

Z-0499-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0499-2026 in the FDA Enforcement Report. Also see FDA recall press releases.