SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION: Device Recall

Recall Details

Recall Number

Z-0499-2026

Classification

Class II

Product Type

Device

Recalling Firm

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

Status

Ongoing

Date Initiated

10/16/2025

Location

Kyoto, Japan

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

1,766 devices

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.

Product Description

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.

Distribution Pattern

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.

Other Recalls by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

• Class II: Risk 09/06/2024
  X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.
• Class II: Risk 09/06/2024
  If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is released, the table may continue to move, which the operator can stop by pressing the stop button.
• Class II: Risk 09/06/2024
  X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.

View all recalls by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION →