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U.S. Department of Health and Human Services

Class 2 Device Recall Mobile DaRt Evolution

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  Class 2 Device Recall Mobile DaRt Evolution see related information
Date Initiated by Firm March 18, 2013
Date Posting Updated June 03, 2013
Recall Status1 Terminated 3 on February 13, 2014
Recall Number Z-1369-2013
Recall Event ID 64803
510(K)Number K080701  
Product Classification System, x-ray, mobile - Product Code IZL
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 .
Code Information In combination with CXDI-70C:

Serial Numbers:

410001F0A004, 410001B13012, 410001B13016, 410001F0A005, 410001B1300E, 410001B13010, 0162S67303, 410001B13018, 410001B1300A, 410001B13017, 410001B1301B, 410001B1301A, 410001B13019, 410001B1301D, 410001B13011, 410001B1301C, 410001B13001, 410001B13015, 410001F0B004, 410001B13008, 410001B13013, 410001F0B005, 410001F0B006, 410001F0A007, 410001B13009, 410001B1300B, 410001B15035, 410001B13014, 410001B14009, 410001B1301F, 410001B14002, 410001B14001, 410001B14006, 410001B14004, 410001B15005, 410001B13002, 410001B1301E, 410001B15016, 410001B15009, 410001B15007, 410001B15006, 410001B1300F, 410001B15001, 410001B15017, 410001B15002, 410001B15020

In combination with CXDI-55C:

Serial Numbers:

0162S65805, 0162S65810, 0162S65808, 0162S66001, 0162S66008, 0162S65809, 0162S66004, 0162S66005, 0162S66009, 0162S66010, 0162S66201, 0162S66202, 0162S66207, 0162S66208, 0162S66206, 0162S66302, 0162S66402, 0162S66409, 0162S66410, 0162S66403, 0162S66501, 0162S66405, 0162S66407, 0162S66406, 0162S66505, 0162S66502, 0162S66503, 0162S66408, 0162S66504, 0162S66603, 0162S66508, 0162S66507, 0162S66510, 0162S66709, 0162S66601, 0162S66610, 0162S66609, 0162S66605

In combination with CXDI-55G

Serial Numbers:, 0162S66205, 0162S66307, 0162S66309, 0162S65901, 0162S66003, 0162S66306, 0162S66308, 0162S66509, 0162S65709, 0162S66606, 0162S66802, 0162S66803
Recalling Firm/
Manufacturer
Shimadzu Medical Systems
20101 S Vermont Ave
Torrance CA 90502-1328
For Additional Information Contact
310-217-8855 Ext. 139
Manufacturer 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.
FDA Determined
Cause 2
Radiation Control for Health and Safety Act
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.
Quantity in Commerce 200 units
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IZL and Original Applicant = SHIMADZU CORP.
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