Recall Z-0499-2026 ยท IYB Tube Mount, X-Ray, Diagnostic
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
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
| Date | Nov 13, 2025 (initiated Oct 16, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 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, OH, OK, OR, PA, PR, RI, SM, SC, SD, TN, TX, VA, WA, and WI. The countries of Dominica, Grand Bahama, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.