CLASS II ONGOING Device recall · Reported 4 Mar 2026 · FDA Enforcement Report
Hitachi Proton Beam Therapy recalled by Hitachi, Ltd. Radiation
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha is recalling Hitachi Proton Beam Therapy, distributed in District of Columbia, Texas. The recall was initiated on 6 Feb 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1430-2026
- FDA event ID
- 98330
- Recalling firm
- Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha, Kashiwa, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Feb 2026
- FDA classified
- 20 Feb 2026
- Reported
- 4 Mar 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 6 Feb 2026 | Recall initiated by company | |
| 20 Feb 2026 | Classified by FDA | +14 days |
| 4 Mar 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Software anomaly in the patient positioning system may result in positional discrepancy.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
Where it was distributed
US distribution to states of: TX, Washington DC
Questions about this recall
Why was it recalled?
Software anomaly in the patient positioning system may result in positional discrepancy.
Which lots are affected?
Serial Number: CRUS01/ UDI: (01)04560333350006(21)CRUS01(11)190920
Where was it sold?
US distribution to states of: TX, Washington DC
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 98330This product is part of a recall event; the main page for the event is Hitachi Proton Beam Therapy System recalled by Hitachi, Ltd. Radiation.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Hitachi Proton Beam Therapy System recalled by Hitachi, Ltd. Radiation | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | Device Malfunction | DC, TX |
More recalls from Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hitachi Proton Beam Therapy System recalled by Hitachi, Ltd. Radiation | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | Device Malfunction | DC, TX |
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