Reported Jul 3, 2019 · Terminated
PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
Hitachi America, Ltd., Power Systems Division
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hitachi America, Ltd., Power Systems Division · 1840 Old Spanish Trl · Houston, TX · 77054-2002
Is this the product you have?
PROBEAT-Vsoftware versions 4.8.1Sand 5.1M Radiation therapy system
- Lot codes and dates
2015B01A01A02
- Amount recalled
- 3
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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