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U.S. Department of Health and Human Services

Class 2 Device Recall MUX100H. Mobile xray system.

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  Class 2 Device Recall MUX100H. Mobile xray system. see related information
Date Initiated by Firm October 28, 2011
Date Posting Updated November 08, 2012
Recall Status1 Terminated 3 on July 26, 2016
Recall Number Z-0262-2013
Recall Event ID 62271
510(K)Number K001517  
Product Classification System, x-ray, mobile - Product Code IZL
Product 0.7U163CS-36
In combination with below systems
MUX-100H, MUX-100D, MobileArt Evolution

Brand Name: MUX-100H.
Classification Name: Mobile x-ray system.
Device Model#MUX-100H.

Product Usage:
The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
Code Information S/N of X-ray tube:, 63049, 63048, 63074, 63081, 63082, 63077, 63350, 63349, 63629, 63647, 63909, 62729, 64214, 66033, 66032, 70070, 70065, 70364, 66327, 66331, 70058, 66325, 70955, 71241, 70920, 71848, 72472, 72462, 73056, 73058, 73341, 73675, 74577, 74563, 74565, 74557, 74558, 74846, 74845, 75455, 75452, 75457, 75728, 75737, 75736, 76059, 76057, 76060, 76054, 76062, 76360, 76366, 76612, 76636, 76336, 76916, 76655, 76647, 76938, 76940, 2XY080646, 2XY0081249, 2XY0081245, 2XY0081543, 2XY0081858, 2XY0081849, 2XY0081855, 2XY0081856, 2XY0081865, 2XY0081862, 2XY0082746, 2XY0082764, 2XY0083055, 2XY0083052, 2XY0083064, 2XY0083051, 2XY0083053, 2XY0083038, 2XY0083063, 2XY0083063, 2XY0083065, 2XY0083343, 2XY0083340, 2XY0083349, 2XY0083354, 2XY0083360, 2XY0083355, 2XY0083646, 2XY0083359, 2XY0083652, 2XY0083670, 2XY0083674, 2XY0083655, 2XY0083673, 2XY0083675, 2XY0083665, 2XY0083645, 2XY0083643, 2XY0083629, 2XY0074577, 2XY0083638, 2XY0083943, 2XY0083671, 2XY0083933, 2XY0083930, 2XY0083925, 2XY0084532, 2XY0084558, 2XY0084546, 2XY0084553, 2XY0084538, 2XY0084846, 2XY0084565, 2XY0084845, 2XY0085124, 2XY0085137, 2XY0085127, 2XY0084578, 2XY0085140, 2XY0085143, 2XY0085141, 2XY0086351, 2XY0084860, 2XY0084856, 2XY0084851, 2XY0084859, 2XY0086344, 2XY0084852, 2XY0086365, 2XY0086364, 2XY0086373, 2XY0086368, 2XY0086665, 2XY0086674, 2XY0087077, 2XY0087371, 2XY0087044, 2XY0087036, 2XY0087041.
Recalling Firm/
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 is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Shimadzu sent an Urgent Voluntary Medical Device Recall - Field Safety Notice letters dated September 19, 2012 to all the affected customers. The letter identifed the description of non-compliance, how to identify the affected products, corrective action plan by Shimadzu and actions to be taken customers. Customers were instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at Shimadzu Medical Systems National Technical Support (800) 228-1429.
Quantity in Commerce 288 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.