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SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4
Recalled August 9, 2023 · FDA recall Z-2270-2023 · 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. · FDA Class II
Units
1836
Sold at
U.S. Nationwide distribution.
Description
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.
Product
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
Manufacturer(s)
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Made in
Japan
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →