FUJIFILM Healthcare Americas Corp recalled 16 CH-200 X-ray machines in the domestic market. The shaft that mounts the X-ray tube unit on the support may break. Protective parts may fail when the shaft breaks during frontward lifting. Healthcare providers should stop using the device immediately and follow recall instructions.
It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact FUJIFILM Healthcare Americas Corporation or your healthcare provider for instructions
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The CH-200 is used in medical imaging to support X-ray tube units during exposure. It is part of hospital or clinic radiology equipment.
A broken mounting shaft can compromise tube support and protective parts, potentially leading to unsafe operation during lifting.
This recall is not described as part of a broader pattern in the provided data.
Hospitals and clinics may face urgent downtime while awaiting guidance. No injuries reported yet, but immediate cessation is advised.
FDA recall page and manufacturer communications listed in the recall notice.
Remedy processing timelines will be provided by FUJIFILM; anticipate several weeks for replacement or service depending on availability.
Keep recall notices, serial numbers, dates, and all correspondence with the manufacturer.
Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33. Distribution: Domestic across AK, CA, FL, IL, MA, NH, OH, WI. Quantity: 16 units. Recall Date: 2025-09-15. Status: ACTIVE.
No injuries or incidents have been reported in the provided data.
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