medical Class II Updated 2019-07-03

Hitachi America, Ltd., Power Systems Division recalls PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation ther

Recalled Product

PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.


Hazard / Issue

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.

Issued by

FDA

Affected States: AZ, MN, TN
Lot/Code Info: 2015B01, A01, A02
View official government recall

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