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Toshiba American Medical Systems Inc recalls Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is intended for use with the ceiling-suspended
Recalled March 30, 2016 · FDA recall Z-1175-2016 · Toshiba American Medical Systems
Hazard
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 Class II
Units
28
Sold at
Nationwide distribution to PA, UT, FL, NY, LA, WV, NJ, OH, WI and TX.
Description
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.
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.
Manufacturer(s)
Toshiba American Medical Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →