FDA-Device2017-10-25Class II
Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. It is intended for use by qualified/trained doctors or technologists on both adult and pediatric subjects taking radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications ca
Toshiba American Medical Systems Inc
Hazard
During an examination images were displayed on the live monitor,but the images were not displayed on the system monitor nor were they saved to the hard disk.
Sold states
USA (nationwide) Distribution
Affected count
US - 96
Manufactured in
PO Box 2068, 2441 Michelle Dr, Tustin, CA, United States
Products
Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. It is intended for use by qualified/trained doctors or technologists on both adult and pediatric subjects taking radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing or lying in prone or supine positions.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0012-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief