Recall Z-2270-2023— SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

Name: FDA recall Z-2270-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-10

Class II · Ongoing

Class II FDA medical device recall by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION, initiated 2023-04-10. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: 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..

Recalling firm: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Classification: Class II
Status: Ongoing
Initiated: 2023-04-10
Firm location: Kyoto, N/A, Japan

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.