Kashiwa, N/A, Japan
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha recalls
1 recall recorded since 2018, most recently on 6 February 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 6 February 2026
- Reason
- Software anomaly in the patient positioning system may result in positional discrepancy.
- Distribution
- US distribution to states of: TX, Washington DC
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1429-2026, Z-1430-2026
- Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
- Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.