PROBEATRecalls & reported problems across all models

We found 2 models of PROBEAT by Hitachi, Ltd. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Dec 16, 2025 and Jan 20, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (1 report).

4 FDA recall records name at least one of these models by its device identifier, 4 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

PROBEAT recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 6, 2026Open, Classified

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

   Z-1430-2026 · Root cause: Software design · Recall details · FDA record ↗

2. Feb 6, 2026Open, Classified

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

   Z-1429-2026 · Root cause: Software design · Recall details · FDA record ↗

3. May 27, 2024Open, Classified

   During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.

   Z-3126-2024 · Root cause: Software design · Recall details · FDA record ↗

4. May 27, 2024Open, Classified

   During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.

   Z-3125-2024 · Root cause: Software design · Recall details · FDA record ↗

Most reported PROBEAT problems

PROBEAT models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PROBEAT PROBEAT-FR

  System, Radiation Therapy, Charged-Particle, Medical
  2 recalls2 reports
• PROBEAT PROBEAT-CR

  System, Radiation Therapy, Charged-Particle, Medical
  2 recalls0 reports

Recent PROBEAT adverse event reports

The 2 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2026Computer Software Problem

  DURING PATIENT SETUP FOR PROTON THERAPY, AFTER CBCT IMAGING, THE HMI DISPLAYED COORDINATES MATCHED THE PLANNED VALUES; HOWEVER, A POSITIONAL DEVIATION OF APPROXIMATELY 3 CM IN THE X-AXIS WAS CONFIRMED USING A LASER MARKER. THIS DISCREPANCY WAS RESOLVED AFTER RE-PERFORMING THE SETUP AND VERIFYING WITH PIAS 2D-2D MATCHING MODE. NO PATIENT INJURY OCCURRED, AND TREATMENT PROCEEDED NORMALLY AFTER CORRECTION. A SOFTWARE ANOMALY IN THE PATIENT POSITIONING SYSTEM (PPS) MAY CAUSE A MISMATCH BETWEEN THE COMMANDED ERROR CORRECTION PARAMETER FLAG IN THE COMMAND DATA AND THE COMMANDED ERROR CORRECTION PARAMETER FLAG IN THE COMMAND DATA OF THE COUCH CONTROLLER, RESULTING IN UNINTENDED POSITIONAL DEVIATION WHILE THE HMI CONTINUES TO DISPLAY THE PLANNED COORDINATES. THE INVESTIGATION SUGGESTS THAT THE ERROR-CORRECTION PARAMETER MAY FAIL TO BE APPLIED AS INTENDED AT A RATE OF (B)(4) OCCURRENCES OUT OF APPROXIMATELY (B)(4) OPERATIONS (REPRODUCTION PROBABILITY OF ABOUT (B)(4)). IN CASE WHERE TREATMENT BEGINS WITHOUT PATIENT POSITION VERIFICATION AFTER A SOFTWARE ANOMALY OCCURS IN THE PPS, THERE IS A RISK OF DELIVERING RADIATION TO NON-TARGET TISSUE, POTENTIALLY CAUSING SERIOUS INJURY. THE INCIDENT WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24121790 ↗
• MalfunctionDec 16, 2025Use of Device Problem; Use of Device Problem

  "DURING POSITIONING IN THE PIAS'S 3D3D MATCHING MODE, WHILE TRANSFERRING CBCT IMAGES FROM CIRS TO PIAS, WHEN THE FLOAT IMAGE SELECTION BUTTON ON THE PIAS SCREEN WAS PRESSED, IT DISPLAYED CBCT IMAGES THAT WERE INSUFFICIENT IN NUMBER. THIS REVEALED A CLEAR DISPLACEMENT IN THE Y-DIRECTION (BODY AXIS DIRECTION) COMPARED TO THE PLANNING CT. SUBSEQUENTLY, UPON CHECKING OIS AT THE CUSTOMER'S SITE ON A LATER DATE, IT WAS FOUND THAT INSTEAD OF THE EXPECTED 160 IMAGES, THERE WERE ONLY 135 IMAGES. IT WAS REPORTED THAT THE INCIDENT OCCURRED ON (B)(6) 2024, AND THE CUSTOMER CONTACTED US ON (B)(6) 2024. FOLLOWING THE ABOVE CUSTOMER CONTACT, WE CONDUCTED A REVIEW OF THE LOGS FOR ALL TREATMENTS. IT WAS FOUND THAT ON (B)(6) 2024, THERE WAS A POSSIBILITY OF COMPLETING 3D3D PATIENT POSITIONING APPROXIMATELY 5MM OFF IN THE BODY AXIS DIRECTION (WITH 5 IMAGES MISSING) AND PROCEEDING WITH TREATMENT. THERE HAVE BEEN NO REPORTS OF HEALTH INJURY. [TREATMENT ON (B)(6) 2024] AFTER PERFORMING POSITION CONFIRMATION IN 2D2D MODE FOLLOWING 3D3D POSITIONING, TREATMENT WAS CARRIED OUT AT THE CORRECT POSITION AFTER REPOSITIONING, SO THERE ARE NO HEALTH INJURY. [TREATMENT ON (B)(6) 2024] THERE IS A POSSIBILITY THAT T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23819356 ↗