Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿… — recall Z-1175-2016
U.S. FDA — Device Enforcement · United States · 2016-01-14 · Class II
As described by U.S. FDA — Device Enforcement: 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,
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Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Nationwide distribution to PA, UT, FL, NY, LA, WV, NJ, OH, WI and TX.
Reported risk: 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.
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