Hitachi Recalls PROBEAT-CR Proton Beam Therapy System Due to Software Anomaly
Hitachi, Ltd. has issued a voluntary recall for a PROBEAT-CR Proton Beam Therapy unit due to a software defect that may cause patient positioning discrepancies.
What Happened
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha, has initiated a voluntary recall of its PROBEAT-CR Proton Beam Therapy system. The recall was triggered by the identification of a software anomaly within the patient positioning system. This defect may result in a positional discrepancy during treatment, potentially affecting the accuracy of the therapy delivery.
Which Products Are Affected
The recall specifically affects one unit of the following medical device:
- Brand Name: Hitachi Proton Beam Therapy
- Model/REF: PROBEAT-CR
- Serial Number: CRUS01
- UDI: (01)04560333350006(21)CRUS01(11)190920
- Recall Number: Z-1430-2026
Distribution of the affected unit was limited to facilities in Texas and Washington D.C.
What You Should Do
The firm initiated the recall process through direct visits to the affected sites. Healthcare facilities and operators using the PROBEAT-CR system with the specified serial number should ensure they have coordinated with Hitachi, Ltd. representatives regarding the software anomaly and any necessary technical corrections.
Why This Matters
In radiation oncology, precise patient positioning is vital for ensuring that therapy is targeted correctly. A software-driven positional discrepancy could lead to radiation being delivered to unintended areas, which poses a risk to patient safety and treatment effectiveness.
Source
Data provided by the FDA under Recall Number Z-1430-2026.
Source: FDA Official Notice