Quick Facts at a Glance
- Recall Date
- January 9, 2026
- Hazard Level
- HIGH
- Brand
- FUJIFILM Healthcare Americas
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
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 Americas
- Product type
- X-ray High-Voltage Generator
- Model numbers
- Model Number: CH-200, (1) Version: 566-16130-23, UDI-DI: 04540217052226, Serial numbers: MP95A9F6A001, MP95A9F6B001, MP95A9F74001, MP95A9F74002, MP95A9F76001 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 9, 2026
Reported by FDA DEVICE
February 11, 2026
RecallRadar source check
February 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.
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. Notification method: Letter
About This Product
The FUJIFILM CH-200 is an X-ray high-voltage generator used in medical imaging. It provides the necessary power for X-ray production, essential for diagnostic procedures in healthcare settings.
Why This Is Dangerous
The welding of electromagnetic contacts can create a continuous electrical current, leading to overheating and potential fire hazards. This defect poses significant operational risks in medical environments where safety is paramount.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers directly, requiring immediate action to ensure patient safety and compliance with medical regulations.
Practical Guidance
How to identify if yours is affected
- Check your device model against the recalled versions.
- Verify the serial numbers against the list provided in the recall notice.
- If in doubt, contact FUJIFILM Healthcare for clarification.
Where to find product info
The model number and serial number can typically be found on the device's identification label located on the back or side panel.
What timeline to expect
Expect a refund or replacement to be processed within 4-6 weeks after you submit your request.
If the manufacturer is unresponsive
- Follow up with FUJIFILM Healthcare through phone or email.
- Keep records of all correspondence and attempts to contact them.
- Consider filing a complaint with the FDA if no resolution is reached.
How to prevent similar issues
- Always check for recalls before purchasing medical devices.
- Ensure devices have updated safety certifications from recognized bodies.
- Follow safety guidelines and training provided for medical equipment.
Documentation advice
Keep copies of all communications regarding the recall, including emails, letters, and any related documents.
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Product Details
The recalled product is the FUJIFILM Healthcare CH-200 X-ray high-voltage generator. Model versions include 566-16130-23, 566-16130-31, and 566-16130-33. The devices were distributed across states such as AK, CA, CT, FL, IL, NH, OH, and WI.
Key Facts
- Recall Date: January 9, 2026
- Distribution: Nationwide in several states
- Quantity: 16 units recalled
- Hazard Level: High
- Manufacturer: FUJIFILM Healthcare Americas
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Safety Guide
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