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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 Systemsee related information
Date Initiated by FirmOctober 16, 2019
Create DateNovember 01, 2019
Recall Status1 Terminated 3 on April 30, 2020
Recall NumberZ-0271-2020
Recall Event ID 84133
510(K)NumberK101888 K150595 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductHitachi 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 ContactAaron 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
ActionAn 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 Commerce39
DistributionThe 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 CycleTPLC 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) Database510(K)s with Product Code = JAK
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