HIGH

FUJIFILM Healthcare Recalls X-ray Tube Support Over Breakage Risk

FUJIFILM Healthcare Americas recalled 16 units of the CH-200 X-ray tube support on September 15, 2025, due to a potential shaft failure. The broken shaft could render protective components ineffective, posing a high risk during operation. Healthcare providers and patients must stop using the device immediately.

Quick Facts at a Glance

Recall Date
September 15, 2025
Hazard Level
HIGH
Brand
FUJIFILM Healthcare
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
8 states
At-Risk Groups
GENERAL

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

Product Details

The recall affects model numbers 566-16130-23, 566-16130-31, and 566-16130-33. These units were distributed in Alaska, California, Florida, Illinois, Massachusetts, New Hampshire, Ohio, and Wisconsin.

The Hazard

The shaft for mounting the X-ray tube unit may break, which can cause the protective parts to fail. This malfunction poses a significant risk to patients and operators during use.

Reported Incidents

No injuries or incidents have been reported at this time. However, the potential for serious injury exists due to the nature of the malfunction.

What to Do

Stop using the device immediately. Contact FUJIFILM Healthcare Americas Corporation or your healthcare provider for further instructions and return processes.

Contact Information

For more information, visit the FUJIFILM Healthcare website or call their customer service at 1-800-XXX-XXXX.

Key Facts

  • Recall date: September 15, 2025
  • Quantity recalled: 16 units
  • Hazard classification: Class II
  • Distribution: AK, CA, FL, IL, MA, NH, OH, WI
View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeX-ray Tube Support
Sold At
Multiple Retailers

Product Details

Model Numbers
566-16130-23
566-16130-31
566-16130-33
04540217052226
04540217057436
+15 more
Affected States
AK, CA, FL, IL, MA, NH, OH, WI
Report Date
October 15, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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