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Toshiba American Medical Systems recalls Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction with the ceil
Recalled September 20, 2017 · FDA recall Z-3111-2017 · Toshiba American Medical Systems
Hazard
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. · FDA Class II
Units
140
Sold at
USA (nationwide) Distribution
Description
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.
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.
Manufacturer(s)
Toshiba American Medical Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →