FDA recall Z-1892-2019

Hitachi America, Ltd., Power Systems Division · Class II · device

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status: Terminated
Initiation date: 2019-04-15
Report date: 2019-07-03
Termination date: 2020-04-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1892-2019