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U.S. Department of Health and Human Services

Class 2 Device Recall INFX8000V

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  Class 2 Device Recall INFX8000V see related information
Date Initiated by Firm August 14, 2015
Date Posted February 09, 2016
Recall Status1 Terminated 3 on May 18, 2016
Recall Number Z-0752-2016
Recall Event ID 73078
510(K)Number K120073  K133535  K143225  K152696  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product INFX-8000V Bi-Plane X-Ray Interventional System



X-ray systems
Code Information Serial Numbers ACA1492002, AAA1492001, W4B1442020, and W4B1432018.
Recalling Firm/
Manufacturer		 Toshiba American Medical Systems Inc
PO Box 2068
2441 Michelle Dr
Tustin CA 92780-7047
For Additional Information Contact
800-521-1968
Manufacturer Reason
for Recall		 When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value to the software. Consequently, the software defined the data as an "abnormal value" and it stopped displaying dose data and the dose data was lost. The following message was displayed, "Dose meter abnormal, Dose info disabled".
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Toshiba's planned action to bring into compliance: 1.Affected customers will be notified using the Customer Notification Letter you provided, 2. revised system software will be installed on the systems to prevent this occurrence from happening, 3. the corrections will be made free of charge, and 4. the corrections will be completed by April 4, 2016. For further questions, please call 1- 800 521-1968.
Quantity in Commerce 4
Distribution US Nationwide Distribution to OH and NY
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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