FDA recall Z-2270-2023

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION · Class II · device

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 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.

Distribution

U.S. Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2023-04-10
Report date: 2023-08-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Kyoto, N/A, Japan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2270-2023