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U.S. Department of Health and Human Services

Class 2 Device Recall Hitachi Scenaria Wholebody Xray CT System

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  Class 2 Device Recall Hitachi Scenaria Wholebody Xray CT System see related information
Date Initiated by Firm October 16, 2019
Create Date November 01, 2019
Recall Status1 Terminated 3 on April 30, 2020
Recall Number Z-0271-2020
Recall Event ID 84133
510(K)Number K150595  K101888  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Hitachi Scenaria Whole-body X-ray CT System
Code Information Scenaria units S5002-S5014, S5017-S5044
Recalling Firm/
Manufacturer		 Hitachi Medical Systems America Inc
1959 Summit Commerce Park
Twinsburg OH 44087-2371
For Additional Information Contact Aaron J. Pierce
330-425-1313 Ext. 2934
Manufacturer Reason
for Recall		 There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action An Urgent Medical Device Correction Notice dated 10/15/19 was sent to customers. Hitachi will inspect all heat controller units for Scenaria systems S5002-S5014 and S5017-S5044 to ensure that the cables and cable loop clamp are affixed as instructed and apply modifications as needed. We expect to begin this process in late October I early November 2019. This action will be implemented by Hitachi Service at no charge to you. Your Service Area Manager will contact you for scheduling. Please contact me if you need further information regarding this report. You can send any questions, comments or requests to recalls@hitachihealthcare.com.
Quantity in Commerce 39
Distribution The devices were distributed to the following US states: CA, FL, GA, IA, IN, MD, MT, NC, NY, OH, OK, SD, TN, TX, WY, and PR. The products were distributed to the following foreign countries: 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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