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U.S. Department of Health and Human Services

Class 2 Device Recall Shimadzu Carm Table

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  Class 2 Device Recall Shimadzu Carm Table see related information
Date Initiated by Firm September 30, 2015
Create Date November 09, 2015
Recall Status1 Terminated 3 on September 12, 2016
Recall Number Z-0251-2016
Recall Event ID 72376
510(K)Number K963888  
Product Classification Medical Imaging Table. - Product Code JAA
Product Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.
Code Information Serial Numbers: 0161H25201 0161H25702 0161H25801 0161H28201 0161H27301  0261H26201  0161H29501  0161H29901  0261H26101  0261H26002 0161H25401 0161H29302 0161H26201 0161H27102 0161H25701 0161H26402 0161H26701 0161H29001 0161H26302 0161H25602 0161H26702 0161H28501 0261H25401 0161H28001  0161H27402  0161H27201
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		 The C-arm may interfere with the table top under certain circumstances.
FDA Determined
Cause 2		 Software design
Action An Urgent Voluntary Medical Device Recall notice was sent on 9/30/2015 to all the customers who purchased the Shimadzu C-arm Table (Catalog No. IVS-110). The notification informs the customers of the description of the issue, the actions to be taken by Shimadzu to correct the issue, and the actions to be taken by the customers. Customers with questions or concerns about the device correction, are instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at (800) 228-1429.
Quantity in Commerce 26 units total (4 units in US)
Distribution Worldwide Distribution. US (Texas, Wisconsin, Ohio, and Connecticut), Iran, India, Saudi Arabia, Serbia, Thailand, Germany, Croatia, Turkey, Lebanon, Korea, and China.
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 = JAA and Original Applicant = SHIMADZU MEDICAL SYSTEMS
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