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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 Recall
Mobile DaRt Evolution
see related information
Date Posted June 03, 2013
Recall Status1 Terminated on February 13, 2014
Recall Number Z-1369-2013
Recall Event ID 64803
Premarket Notification
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, California 90502-1328
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: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IZL and Original Applicant = SHIMADZU CORP.
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