FDA-Device2025-10-15Class II
FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
FUJIFILM Healthcare Americas Corporation
Hazard
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.
Sold states
Domestic: AK, CA, FL, IL, MA, NH, OH, WI.
Affected count
16 units
Manufactured in
81 Hartwell Ave Ste 300, Lexington, MA, United States
Products
FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0044-2026Don't want to check this manually?
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