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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 Initiated by Firm October 28, 2011
Date Posted November 08, 2012
Recall Status1 Terminated 3 on July 26, 2016
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
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 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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