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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 29, 2018
Create Date August 17, 2018
Recall Status1 Terminated 3 on April 27, 2020
Recall Number Z-2839-2018
Recall Event ID 80671
510(K)Number K150595  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Hitachi Scenaria CT system

Product Usage:
The SCENARIA CT system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the SCENARIA can be post processed by the SCENARIA to provide additional information. Post processing capabilities included in the SCENARIA software include CT angiography (CTA), Multiplanar reconstruction (MPR) and volume rendering. Volume datasets acquired by the SCENARIA Phase 3 can be transferred to external devices via a DICOM standard interface. The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.
Code Information S7004
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 received a complaint where, during patient positioning, the technologist was adjusting the patient table height and the table failed to stop when the control was released and contacted the CT gantry. The problem could not be duplicated at the site, so to avoid further issues while a root cause investigation was pursued, Hitachi choose to add an optional touch sensor to the gantry to add a redundant level of protection. It is conceivable that a patient s extremity may be caught between the tabletop and the gantry surface during uncontrolled motion or that the table contact of the gantry might cause internal damage to the unit.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 6/19/18, the firm was notified of the problem at a customer site. The firm is currently investigating the underlying cause to formulate a planned corrective action. On 6/29/18, the firm took a preventive measure at the site which originated the complaint: Hitachi added an optional touch sensor to the unit to lessen the chance of injury. The firm may take additional corrective action on other units distributed to customers once root cause investigation is complete.
Quantity in Commerce 1
Distribution US Distribution to one customer in TX.
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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