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
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
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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