Shimadzu recalls ceiling X-ray tube support models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed systems due to potential shaft breakage that could cause the X-ray tube assembly to come off the rotating shaft.
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.
Shimadzu is recalling ceiling X-ray tube support models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed systems because of a potential issue with the shaft that could cause the X-ray tube assembly to come loose. This could lead to the X-ray tube detaching during use, posing a risk of injury to patients or staff.
The shaft that mounts the X-ray tube assembly has a potential issue that could cause the assembly to come off the rotating shaft. If this happens during use, the X-ray tube could become detached, potentially causing injury to patients or medical staff.
Healthcare facilities using these X-ray tube supports for medical imaging are most at risk. Patients and medical staff who use these systems could be affected if the X-ray tube becomes detached during procedures.
Check for ceiling X-ray tube supports labeled CH-200 or CH-200M used with RADspeed, SonialVision, or FLUOROspeed systems. The product includes specific serial numbers and UDI codes listed in the recall notice.
Verify if your X-ray tube support has the model numbers CH-200 or CH-200M and is used with RADspeed, SonialVision, or FLUOROspeed systems.
Reach out to Shimadzu for assistance with the recall process or to confirm if your unit is affected.
The shaft that mounts the X-ray tube assembly has a potential issue that could cause the assembly to come off the rotating shaft during use.
Check for model numbers CH-200 or CH-200M used with RADspeed, SonialVision, or FLUOROspeed systems. The recall includes specific serial numbers and UDI codes listed in the notice.
No, but you should check if your unit is affected and contact Shimadzu for guidance on next steps.
We’ve drafted a message you can send Shimadzu to request your refund or repair — edit it as you like.
Subject: Recall Z-0499-2026 — Shimadzu Shimadzu Hello, I own a Shimadzu that is covered by recall Z-0499-2026 from Shimadzu. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
