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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 Posted November 08, 2012
Recall Status1 Open
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/
Manufacturer
Shimadzu Medical Systems
20101 S Vermont Ave
Torrance CA 90502-1328
310-217-8855
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 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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