Quick Facts at a Glance
- Recall Date
- September 15, 2025
- Hazard Level
- HIGH
- Brand
- FUJIFILM Healthcare
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 8 states
- At-Risk Groups
- GENERAL, PREGNANT
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- FUJIFILM Healthcare
- Product type
- X-ray imaging system component (X-ray tube mounting shaft)
- Model numbers
- 566-16130-23, 566-16130-31, 566-16130-33, 04540217052226, 04540217057436, 04540217057450, MP95A8F5A001, MP95A9F6A001 +12 more
- Sold at
- Unknown
- Where affected
- AK, CA, FL, IL, MA, NH, OH, WI
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 15, 2025
Reported by FDA DEVICE
October 15, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
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
About This Product
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.
Why This Is Dangerous
A broken mounting shaft can compromise tube support and protective parts, potentially leading to unsafe operation during lifting.
Industry Context
This recall is not described as part of a broader pattern in the provided data.
Real-World Impact
Hospitals and clinics may face urgent downtime while awaiting guidance. No injuries reported yet, but immediate cessation is advised.
Practical Guidance
How to identify if yours is affected
- Verify the device model number 566-16130-23, 566-16130-31, or 566-16130-33 on the unit label.
- Check the recall notice for status and instructions.
- Contact FUJIFILM Healthcare Americas for guidance.
Where to find product info
FDA recall page and manufacturer communications listed in the recall notice.
What timeline to expect
Remedy processing timelines will be provided by FUJIFILM; anticipate several weeks for replacement or service depending on availability.
If the manufacturer is unresponsive
- Escalate to hospital facilities management and request escalation with FUJIFILM.
- File a safety report with the facility's risk management department.
How to prevent similar issues
- Verify shaft integrity before use and during routine checks.
Documentation advice
Keep recall notices, serial numbers, dates, and all correspondence with the manufacturer.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
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.
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- Domestic distribution: AK, CA, FL, IL, MA, NH, OH, WI
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.
