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U.S. Department of Health and Human Services

Class 2 Device Recall INFX8000H Fluoroscopic XRay Systems

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  Class 2 Device Recall INFX8000H Fluoroscopic XRay Systems see related information
Date Initiated by Firm December 29, 2017
Create Date March 02, 2018
Recall Status1 Terminated 3 on November 29, 2023
Recall Number Z-0845-2018
Recall Event ID 79153
510(K)Number K082830  
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
Product INFX-8000H Fluoroscopic X-Ray Systems
Code Information Serial Numbers: A5B1672001, AFA1692002
Recalling Firm/
Manufacturer		 Toshiba American Medical Systems Inc
PO Box 2068
2441 Michelle Dr
Tustin CA 92780-7047
For Additional Information Contact
714-730-5000
Manufacturer Reason
for Recall		 During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.
FDA Determined
Cause 2		 Process control
Action A recall notification letter was sent to affected consignees on 12/29/2017. The following information was included in the notification letter: Should this problem occur prior to the above corrective action and in the middle of a clinical case, you will be able continue the case tentatively. The x-ray emissions will be still available and the inhibited ceiling support device can be overridden by pressing the override switch on the left side of the operation console. If any abnormalities are found during use, please stop using your system and contact your Toshiba service representative. Please share this information with all users and reviewing radiologist as well as clinical engineering and the biomedical group at your facility.
Quantity in Commerce 2 units
Distribution United States
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 = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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