FDA-Device2019-07-03Class II
PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
Hitachi America, Ltd., Power Systems Division
Hazard
There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Positioning Image Analysis System) software installed in the PROBEAT-V, proton therapy systems.
Sold states
Distributed to accounts located in AZ, MN, and TN. Foreign distribution to Japan.
Affected count
3
Manufactured in
1840 Old Spanish Trl, N/A, Houston, TX, United States
Products
PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1892-2019Don't want to check this manually?
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