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.
Enforcement
- Recall Number
- Z-1175-2016
- Event ID
- 73064
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Toshiba American Medical Systems Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 30, 2016
- Initiation Date
- January 14, 2016
- Classification Date
- March 21, 2016
- Termination Date
- February 24, 2017
- Address
- PO Box 2068, 2441 Michelle Dr, Tustin, CA, 92780-7047, United States
Description
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.
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.
Serial number : USB1522023
Nationwide distribution to PA, UT, FL, NY, LA, WV, NJ, OH, WI and TX.
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