FDA-Device2023-08-09Class II
Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed 300 and X1 units
Hazard
Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing so service is required to install a cable, bracket, and label behind the bracket, indicating when service is required, to eliminate the risk of the device falling.
Sold states
U.S. Nationwide distribution.
Affected count
1836
Manufactured in
Nishinokyo Kuwabara -Cho, Nakagyo-Ku; 1, Kyoto, N/A, Japan
Products
Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed 300 and X1 units
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2270-2023Don't want to check this manually?
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