Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The c

FDA device recall Z-0499-2026 · posted 2025-11-13 · Open, Classified

Recall details

Recalling firm

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

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.

Action taken

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

Root cause

Device Design

Status

Open, Classified

Product code

IYB

Quantity affected

1,766 devices

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,

Date initiated

2025-10-16

Date posted

2025-11-13

Location

Kyoto, Japan