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Shimadzu Medical Systems recalls Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiograph
Recalled June 12, 2013 · FDA recall Z-1369-2013 · Shimadzu Medical Systems
Hazard
The recall was initiated because Shimadzu Corporation has identified a potential issue in certain manufacturing lots of the Shimadzu MobileDaRt Evolution in combination with CXDI-70C, CXDI-55C, and CXDI-55G. As a result of Shimadzu's investigation, there is a potential risk for screws becoming loose inside the Shimadzu Mobile X-ray systems. · FDA Class II
Units
200 units
Sold at
US Nationwide Distribution
Description
The recall was initiated because Shimadzu Corporation has identified a potential issue in certain manufacturing lots of the Shimadzu MobileDaRt Evolution in combination with CXDI-70C, CXDI-55C, and CXDI-55G. As a result of Shimadzu's investigation, there is a potential risk for screws becoming loose inside the Shimadzu Mobile X-ray systems.
Product
Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of out patients in emergency .
Manufacturer(s)
Shimadzu Medical Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →