Skip to content
RecallWatchMedical Device Safety
Class IIOngoingZ-0499-2026

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISIONKyoto, JapanReported Nov 19, 2025 · 8 months ago
Legal News Analyst ·

Reason for recall

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI codeModel Numbers
    400 affected lots
    3ZC5C2A840143ZC5C2A850033ZC5C2A770133ZC5C2A860133ZC5C2A750123ZC5C2A760023ZC5C2A760163ZC5C2A76026
    +392 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-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

What the firm is doing

On 10/16/2025, the firm emailed an "Urgent: Voluntary Medical Device Recall Notice" to customers informing them that, the firm has identified potential problems with the Ceiling Tube Support that consists of an X-ray Tube holder with has a rotation mechanism. There is the potential for rotation shaft cracking due to periodic movements. If the cracks grow, the retaining shaft may eventually break. The mechanical stopper is equipped to prevent X-ray tube assembly from coming off even if the retaining shaft breaks. It may not work effectively only if the shaft breaks while being operated toward front while lifting. X-ray tube assembly weighs 40 kg and if it were to fall off and contact the patient or the operator, it could cause critical injuries. Customer are instructed to: - Perform the daily inspection described in the CH-200/CH-200M operation manual to check for wobbles or shakes, misalignment of the light irradiation position, etc. If any abnormality is found, discontinue use and contact our service provider. When rotating the X-ray tube unit, do not hit the stopper at the end. If the stopper is hit hard, in the unlikely event that a crack has already occurred, a large impact may be applied, and the growth of the crack may be accelerated. In the case of electric rotation, it is controlled by software and does not hit the stopper. - Do not rotate the X-ray tube over or near the patient. For questions - Shimadzu Medical Systems National Technical Support: Toll Free: (844)487-2767 Available 8:00 to 5:00 PM, Monday - Friday

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

More Class II recalls