PROBEAT recallZ-1429-2026 · Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha · initiated Feb 6, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Software anomaly in the patient positioning system may result in positional discrepancy.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-1429-2026
- Status
- Open, Classified
- Initiated by the company
- Feb 6, 2026
- Posted by the FDA
- Feb 20, 2026
- Recalling firm
- Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
- Quantity
- 1
- Product code
- LHN
- FDA submissions
- K232032
- Distribution
- US distribution to states of: TX, Washington DC
Product description
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Code information (models, lots, serial numbers)
Serial number: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- PROBEAT PROBEAT-FRHitachi, Ltd. · System, Radiation Therapy, Charged-Particle, Medical2 recalls2 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 98330).
- Z-1430-2026 · Open, ClassifiedBrand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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