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.
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 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 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.
No injuries or incidents have been reported at this time. However, the potential for serious injury exists due to the nature of the malfunction.
Stop using the device immediately. Contact FUJIFILM Healthcare Americas Corporation or your healthcare provider for further instructions and return processes.
For more information, visit the FUJIFILM Healthcare website or call their customer service at 1-800-XXX-XXXX.
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