Device product
Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction 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 trans mission/ output of images to external devices.
Z-3111-2017
Product summary
- Event
- Event 77888
- Status
- Terminated
- Classification
- Class II
- Quantity
- 140
- Official record key
device-enforcement:Z-3111-2017
Official wording
Reason: It was discovered during a procedure that when the operator made an exposure on the wireless x-ray detector and the image data was sent to the digital radiography system, and error message was displayed " System Error (2063)" which required a reboot and loss of the image.
Code information: Serial No. W8B1572022
Distribution pattern: USA (nationwide) Distribution
Derived failure modes
-
Unknown
It was discovered during a procedure that when the operator made an exposure on the wireless x-ray detector and the image data was sent to the digital radiography system, and error message was displayed " System Error (2063)" which required a reboot and loss of the image.