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U.S. Department of Health and Human Services

Class 2 Device Recall MobileArt Evolution, MobileDaRt Evolution

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 Class 2 Device Recall MobileArt Evolution, MobileDaRt Evolution see related information
Date Posted November 08, 2012
Recall Status1 Open
Recall Number Z-0263-2013
Recall Event ID 62271
510(K)Number K041763 
Product Classification System, x-ray, mobile - Product Code IZL
Product 0.7/1.3U163CS-36
In combination with below systems
MobileArt Evolution, MobileDaRt Evolution

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:
64510
66036
66026
66027
71866
70641
72470
72740
72735
73360
73365
2XY0084531
73372
73679
73671
73966
74248
74258
74546
74548
74291
74556
74832
74834
74833
74829
74837
76058
76326
76069
76355
76364
76361
76356
76358
76363
76367
2XY0080666
80666
2XY0080650
2XY0080345
2XY0080649
2XY0080656
2XY0082453
2XY0082456
2XY0082461
2XY0082748
2XY0083039
2XY0075448
2XY0082750
2XY0083070
2XY0082778
2XY0083047
2XY0083058
2XY0083680
2XY0083627
2XY0083633
2XY0083951
2XY0084556
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 133 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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