Class II U.S. Food and Drug Administration

Brand Name: Hitachi Proton Beam Therapy System Ref: Probeat-Fr recall: Software anomaly in the patient positioning system may result in positional

Recall published 8 months ago

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

The hazard: Device malfunction

The notice describes a specific failure mode. That detail is what a clinician needs, because the right action differs sharply between a monitor, an implant and a test kit.

What the notice says: Software anomaly in the patient positioning system may result in positional discrepancy.

Why it matters: The device may not perform as intended — a mechanical failure, a software defect, an inaccurate reading, or an alarm that does not sound. For a device someone depends on, the consequence of the failure is usually worse than the failure itself.

Symptoms and when to call a doctor

If the device supports a vital function, do not disable or remove it on your own judgement. Contact the clinician who prescribed or fitted it, and use the back-up arrangement they gave you. Go to an emergency department if the symptoms the device is meant to manage are getting worse, or if an implanted device gives an unexpected alarm or shock.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-1429-2026
Published
March 4, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Product type
Medical devices
Units affected
1
Distribution
District of Columbia, Texas, Washington
Made in
Japan
Lot / code info
Serial number: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01
UPC codes
04560333350204

Products covered by this recall

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

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 04560333350204

Serial number

On the rating plate, often next to the date of manufacture.

  • PTFR-01
  • UDI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Malfunction

Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha — The notice describes a specific failure mode. That detail is what a clinician needs, because the right action differs sharply between a monitor, an implant and a test kit.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.
  2. Report device problems to the FDA through MedWatch — that database is where this recall came from.
  3. If the device is implanted, or you depend on it daily, speak to your clinician before changing anything about how you use it.
  4. Check whether the remedy is a software update, and if so confirm afterwards in the device menu that the version actually changed.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha — 44-141-1,W 226, Kashiwa

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha… recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 04560333350204. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Which states were affected?

The notice lists District of Columbia, Texas, Washington.

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