Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed Recalled by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Due to Due to an issue (potential breakage) with the...

Date: October 16, 2025
Company: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION directly.

Affected Products

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.

Quantity: 1,766 devices

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report