FDA-Device2013-06-12Class II
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 .
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.
Sold states
US Nationwide Distribution
Affected count
200 units
Manufactured in
20101 S Vermont Ave, N/A, Torrance, CA, United States
Products
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 .
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1369-2013Don't want to check this manually?
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