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U.S. Department of Health and Human Services

Class 2 Device Recall Toshiba DRAD3000E FPD Wireless system

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  Class 2 Device Recall Toshiba DRAD3000E FPD Wireless system see related information
Date Initiated by Firm January 14, 2016
Date Posted March 21, 2016
Recall Status1 Terminated 3 on February 24, 2017
Recall Number Z-1175-2016
Recall Event ID 73064
510(K)Number K133553  
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
Product Toshiba DRAD-3000E FPD Wireless System

Product Usage The DRAD-3000¿ is intended for use with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck, and limbs. This system is used for image acquisition, image display and transmission/output or images to external devices.
Code Information Serial number : USB1522023
Recalling Firm/
Toshiba American Medical Systems Inc
PO Box 2068
2441 Michelle Dr
Tustin CA 92780-7047
For Additional Information Contact
Manufacturer Reason
for Recall
When a user performed radiography using the wireless FPD, a message window appeared on the monitor stating that imaging transmission was not completed with no radiographic image. It also indicated to select the "OK" button to re-acquire the image data or to select the¿'Cancel" button to cancel the re-acquisition. As instructed the user selected "OK" and the same message window appeared. This same operation was repeated several times with the identical result - no image. Finally, the user selected "Cancel" and the re-acquisition was terminated.
FDA Determined
Cause 2
Radiation Control for Health and Safety Act
Action Toshiba's planned action: 1."Toshiba America Medical Systems, Inc. (TAMS) will advise contact customers to stop using the system if any abnormalities are found using the system. 2. TAMS will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that TAMS will without charge, remedy the defect or bring the product into compliance. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. TAMS will implement this CAP by June 30, 2016. Customers with questions were advised to call 301-796-5910. For questions regarding this recall call 714-730-5000.
Quantity in Commerce 28
Distribution Nationwide distribution to PA, UT, FL, NY, LA, WV, NJ, OH, WI and 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 = JAA and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.