PROBEAT PROBEAT-FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04560333350204), 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).

2 FDA recall records name this device's identifier, 2 still open.

2 other recalls cover devices cleared under the same FDA submission (K232032); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 6, 2026Open, Classified

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

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

2. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K232032. One submission often covers many models, so check the product and lot details in each record.

• Z-3127-2024 · May 27, 2024 · Open, Classified
  Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V is a proton beam irradiation system, which provides a
• Z-3126-2024 · May 27, 2024 · Open, Classified
  Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-CR is a proton beam irradiation system, which provides