Recall Z-1175-2016 · JAA System, X-Ray, Fluoroscopic, Image-Intensified

Toshiba American Medical Systems Inc

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/outp

Date	Mar 21, 2016 (initiated Jan 14, 2016)
Status	Terminated
Reason	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.
Root cause	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
Quantity	28
Distribution	Nationwide distribution to PA, UT, FL, NY, LA, WV, NJ, OH, WI and TX.
FDA record	Open on fda.gov

510(k) clearances named in this recall

K133553

KALARE
Toshiba America Medical Systems, In.C, Jun 13, 2014