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 .
FDA Recall Z-1369-2013 · Posted 2013-06-03
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Recalling FirmShimadzu Medical Systems
Recall StatusTerminated
Product CodeIZL
Date Initiated2013-03-18
Date Terminated2014-02-13
Product Quantity200 units
Reason for Recall
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.
Firm Action
Shimadzu sent a recall letter dated March 18, 2013, to all customers who purchased the Shimadzu MobileDart Evolution in combination with CXDI-70C, CXDI-55C, or CXDI-55G. The letter informs the customers of the problem identified and the actions to be taken. Customers are instructed to follow the instructions of the recall notice step by step. Customers with questions are instructed to contact their local Shimadzu representatives or contact Shimadzu National Technical Support at (800) 228-1429.
A Field Safety Notice dated March 18, 2013, was sent to Service Managers in regards to the Shimadzu Mobile DaRt Evolution in combination with CXDI-70C, CXDI-55C, or CXDI-55G. The Safety Notice informs the Service managers of the problems identified and the actions to be taken.
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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