CLASS II ONGOING Device recall · Reported 4 Mar 2026 · FDA Enforcement Report

Hitachi Proton Beam Therapy System recalled by Hitachi, Ltd. Radiation

Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha is recalling Hitachi Proton Beam Therapy System, distributed in District of Columbia, Texas, Washington. The recall was initiated on 6 Feb 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial number: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01
Quantity recalled1

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-1429-2026
FDA event ID
98330
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

Timeline

6 Feb 2026Recall initiated by company
20 Feb 2026Classified by FDA+14 days
4 Mar 2026Published 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 System Ref: PROBEAT-FR

Where it was distributed

US distribution to states of: TX, Washington DC

District of ColumbiaTexasWashington

Questions about this recall

Is Hitachi Proton Beam Therapy System recalled?

Yes. Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha recalled Hitachi Proton Beam Therapy System on 6 Feb 2026. The recall is Class II and its status is Ongoing. Recall number Z-1429-2026.

Why was it recalled?

Software anomaly in the patient positioning system may result in positional discrepancy.

Which lots are affected?

Serial number: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

All 2
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIHitachi Proton Beam Therapy recalled by Hitachi, Ltd. RadiationHitachi, Ltd. Radiation Oncology Systems, KashiwanohaDevice MalfunctionDC, TX, WA

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