Z-3111-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 20, 2017
- Initiation Date
- March 23, 2017
- Termination Date
- October 23, 2020
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 140
Product Description
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 Pattern
USA (nationwide) Distribution
Code Information
Serial No. W8B1572022