Z-1429-2026Class II

Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR

Name: Z-1429-2026 Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Creator: Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Published: 2026-02-06
License: https://open.fda.gov/license/

Hitachi High-Tech Corp., Kashiwanoha / initiated 2026-02-06 / Open, Classified / root cause: software

FDA source

Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha began a recall of Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR on 2026-02-06. FDA classified it as Class II and gives the reason as "Software anomaly in the patient positioning system may result in positional discrepancy". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1429-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-06
Posted: 2026-02-20
Recalling firm: Hitachi High-Tech Corp., Kashiwanoha
Product: Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: Software anomaly in the patient positioning system may result in positional discrepancy.
Root cause tag: software
FDA root cause: Software design
Action: Between the dates of February 5-11, 2026, Hitachi, Ltd, issued an "URGENT: MEDICAL DEVICE RECALL" notification dated January 21, 2026, via Service Team Manager to affected consignees. Hitachi is asking consignees to take the following actions: 1. Until the PPS software has been updated with the corrected version, users are instructed to follow the System Operation instruction in the document. 2. Users are also asked to post the document in a prominent space and sign its cover. 3. Complete and return the acknowledgment and receipt form. Action by the firm: Hitachi plans to update the PPS software to a corrected version that prevents the mismatch between the commanded error correction parameter and the internal variable. starting in late March 2026 and the users will be contacted after the update. If you have any questions, please call QA Manager at Tel: (408) 986-6300. Monday through Friday, 8:00 AM to 5:00 PM, Central Time.
Quantity in commerce: 1
Distribution: US distribution to states of: TX, Washington DC
Product codes and lots: Serial number: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1429-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1429-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20
Z-1430-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20

Product code LHN

K232032Class IIProbeat-FrHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha / cleared 2024-01-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)