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Hitachi America, Ltd., Power Systems Division recalls PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
Recalled July 3, 2019 · FDA recall Z-1892-2019 · 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. · FDA Class II
Units
3
Sold at
Distributed to accounts located in AZ, MN, and TN. Foreign distribution to Japan.
Description
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.
Product
PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
Manufacturer(s)
Hitachi America, Ltd., Power Systems Division
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →