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U.S. Department of Health and Human Services

Class 2 Device Recall Hitachi SCENARIA CT System

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  Class 2 Device Recall Hitachi SCENARIA CT System see related information
Date Initiated by Firm June 30, 2015
Create Date August 11, 2016
Recall Status1 Terminated 3 on November 01, 2016
Recall Number Z-2392-2016
Recall Event ID 74714
510(K)Number K101888  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
Code Information Serial #'s: S5002-S5014; S5017-S5038
Recalling Firm/
Manufacturer
Hitachi Medical Systems America Inc
1959 Summit Commerce Park
Twinsburg OH 44087-2371
For Additional Information Contact Mr. Douglas J. Thistlethwaite
330-425-1313 Ext. 3720
Manufacturer Reason
for Recall
The firm discovered that the centrifugal force applied to the power supply may cause it to fail over time. The exam performed at the time of the failure will likely be lost, resulting in the need to rescan the patient.
FDA Determined
Cause 2
Component design/selection
Action Hitachi sent an Device Correction Notice dated April 1, 2015, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. Customers were informed that there is a problem with the Hitachi Medical Systems America, Inc.CT system; the issue is with a power supply in the CT gantry sub-system. During fast rotation (i.e., 35 sec), the centrifugal force applied to the power supply may cause it to fail over time. For further questions, please call (330) 425-1313 ext. 3720.
Quantity in Commerce 33 units
Distribution US Distribution to the states of : CA, FL, GA, IA, IL, IN, MD, NC, NY, OH, PA, SD, TN, TX & WY., and Internationally to Brazil and Mexico.
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 = JAK and Original Applicant = HITACHI MEDICAL SYSTEMS AMERICA, INC.
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