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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 Posted June 03, 2013
Recall Status1 Terminated 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
310-217-8855 Ext. 139
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 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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