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U.S. Department of Health and Human Services

Class 2 Device Recall Angio WorkStation XIDFAWS801v6.00, v6.01, and V6.10 System: INFX8000V BiPlane System

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  Class 2 Device Recall Angio WorkStation XIDFAWS801v6.00, v6.01, and V6.10 System: INFX8000V BiPlane System see related information
Date Initiated by Firm February 24, 2016
Date Posted July 18, 2016
Recall Status1 Terminated 3 on April 25, 2017
Recall Number Z-2188-2016
Recall Event ID 74473
510(K)Number K150967  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System
Code Information Model Number - XIDF-AWS801
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 a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS expected value. It was found that the software incorrectly calculated the PSD value when the x-ray condition of the frontal plane and the lateral plane are the same. It incorrectly used in the calculation a dose value from a previous exposure.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Toshiba Medical Systems (TAMS) planned action to bring product into Compliance: 1.TAMS will install the software and perform testing to ensure the software update was effective. 2. The customer notification letter which includes a statement that TAMS will, without charge, remedy the defect or bring the product into compliance. . If you have any questions regarding this, please feel free to contact your local Toshiba representative at (800) 521-1968.
Quantity in Commerce 23
Distribution US Distribution to the states of : NC, NY, TX, GA, CA, AZ, IL, FL,MA, MO and DE.
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 = OWB and Original Applicant = Toshiba Medical Systems Corporation
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