# FDA recall Z-0499-2026

> **SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION** · Class II · device recall initiated 2025-10-16.

## 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 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.

## 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.

## Key facts

- **Recall number:** Z-0499-2026
- **Recalling firm:** SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-16
- **Report date:** 2025-11-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kyoto, Japan

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0499-2026

## Citation

> AI Analytics. FDA recall Z-0499-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0499-2026. Source: US FDA. Licensed CC0.

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