FDA-Device2012-09-05Class II
Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation.
Toshiba American Medical Systems Inc
Hazard
1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) are selected and reconstructed at one time, incorrect couch positions and scan times are displayed on the reconstructed images for the data acquired by Return scanning, while all related information is displayed on the reco
Sold states
Nationwide distribution: USA including states of: AL, AR, CA, CO, FL, GA, KY, MA, MD, MT, ND, NJ, NV, NY, OH, PA and Puerto Rico.
Affected count
24 Systems
Manufactured in
2441 Michelle Dr, P.O. Box 2068, Tustin, CA, United States
Products
Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2282-2012Don't want to check this manually?
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