United StatesHitachi Proton Beam Therapy System models REF: PROBEAT-FR (Serial PTFR-01, UDI (01)04560333350204(11)240112(21)PTFR-01) and REF: PROBEAT-CR (Serial CRUS01, UDI (01)04560333350006(21)CRUS01(11)190920) that were distributed in the U.S. to Texas and Washington, D.C. are affected. They were recalled because a software anomaly in the patient positioning system may result in a positional discrepancy.
What's being recalled
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
Recalling firm: Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha, Kashiwa, N/A, Japan.
How to identify it
Serial number: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01 Serial Number: CRUS01/ UDI: (01)04560333350006(21)CRUS01(11)190920
The hazard
Software anomaly in the patient positioning system may result in positional discrepancy.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US distribution to states of: TX, Washington DC
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)