FDAFDA · Food and drugs·Recall number Z-3111-2017
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.
Published September 20, 2017 · Recall initiated: March 23, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- Toshiba American Medical Systems
- Distributor
- USA (nationwide) Distribution
- Lot
- Serial No. W8B1572022
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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