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U.S. Department of Health and Human Services

Class 2 Device Recall MUX100, MUX100H Xray System

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  Class 2 Device Recall MUX100, MUX100H Xray System see related information
Date Initiated by Firm November 15, 2013
Date Posted March 07, 2014
Recall Status1 Terminated 3 on June 25, 2015
Recall Number Z-1150-2014
Recall Event ID 67353
510(K)Number K001517  
Product Classification System, x-ray, mobile - Product Code IZL
Product Mobile X-ray System, Model: MUX-100, MUX-100H

Product Usage:
The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannnot move and/or of outpatients in emergency
Code Information Serial No.  0262P70907 0262P70908 0262P70909 0262P70910 0262P71001 0262P71002 0262P71003 0262P71004 0262P71005 0262P71006 0162Z01901 0162Z01902 0162Z01903 0162Z01904 0162Z01905 0162Z02002 0162Z02003 0162Z02004 0162Z02005 0162Z02006 0162Z02007 0162Z02008 0162Z02009 0162Z02101 0162Z02108 0162Z02204 0162Z02205 0162Z02302 0162Z02303 0162Z02304 0162Z02305 0162Z02306 0162Z02307 0162Z02308 0162Z02309 0162Z02310 0262Z00205 0262Z00206 0262Z00207 0262Z00208 0262Z00209 0262Z00210 0262Z00307 0262Z00308 0262Z00309 0262Z00310 0262Z00401 0262Z00402 0262Z00403 0262Z00404 0262Z00610 0262Z00701 0262Z00702 0262Z00703 0262Z00704 0262Z00705 
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		 Shimadzu Corporation is recalling the Shimadzu Mobile X-ray Sytems (MUX-100 and MUX-100H) because the connecting metal plate which connects the main chassis and the column of MUX-100 may crack.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action A Field Safety Notice and an Urgent Voluntary Medical Device Recall Notice were sent to customers to inform them that SHIMADZU CORPORATION has identified a potential issue in certain manufacturing lots of the Shimadzu Mobile X-ray Systems. Customers are informed that as a result of their investigation, it has been learned that the connecting work of very few column used in specific lots for the MUX series was not done correctly, and it may cause a crack. Therefore, if the machine is continuously used in that condition, there is the possibility that the column will start to lean. The notices informs the customers of the actions to be taken. Customers are instructed to contact Shimadzu Medical Systems National Technical Support at (800) 228-1429.
Quantity in Commerce 56 units
Distribution USA 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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