Reported Sep 20, 2017 · Terminated
Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction with the…
Toshiba American Medical Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Toshiba American Medical Systems · 2441 Michelle Dr · Tustin, CA · 92780-7047
Is this the product you have?
- 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.
- Lot codes and dates
- Serial No. W8B1572022
- Amount recalled
- 140
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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