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Recall Observatory FDA recall evidence

Device product

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

Z-1892-2019

April 15, 2019

Class II

Product summary

Firm
Hitachi America, Ltd., Power Systems Division
Event
Event 83056
Status
Terminated
Classification
Class II
Quantity
3
Official record key
device-enforcement:Z-1892-2019

Official wording

Reason: 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.

Code information: 2015B01, A01, A02

Distribution pattern: Distributed to accounts located in AZ, MN, and TN. Foreign distribution to Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.