FDA recall Z-3111-2017

Toshiba American Medical Systems · Class II · 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.

Reason for recall

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.

Distribution

USA (nationwide) Distribution

Key facts

Status
Terminated
Initiation date
2017-03-23
Report date
2017-09-20
Termination date
2020-10-23
Voluntary/Mandated
FDA Mandated
Location
Tustin, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3111-2017