Pinnacle Radiation Therapy Planning System 18.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884838103566), received between Jun 30, 2022 and Oct 18, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (2 reports).

3 FDA recall records name this device's identifier, 3 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 5, 2025Class IIOpen, Classified

   Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.

   Z-2570-2025 · Root cause: Software design · Recall details · FDA record ↗

2. Jul 17, 2025Class IIOpen, Classified

   Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,

   Z-2239-2025 · Root cause: Software change control · Recall details · FDA record ↗

3. Aug 30, 2022Class IIOpen, Classified

   When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen.

   Z-1744-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2024Application Program Problem; Application Program Problem

  DURING INTERNAL TESTING AN ISSUE WAS FOUND IN WHICH USERS ARE ABLE TO SELECT DATASETS FROM DIFFERENT SCANS FOR STOPPING POWER RATIO (SPR) GENERATION. THERE IS NO ALLEGATION OF A DEATH OR SERIOUS INJURY. A DEFECT WAS FILED AND HAS BEEN EVALUATED BY THE DEFECT REVIEW BOARD (DRB) AND SCORED AS AN UNACCEPTABLE SAFETY DEFECT. AN ISSUE IMPACT ASSESSMENT (IIA) HAS BEEN TRIGGERED AND PHILIPS IS INVESTIGATING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20481319 ↗
• MalfunctionOct 18, 2024Application Program Problem; Application Program Problem

  DURING INTERNAL TESTING AN ISSUE WAS FOUND IN WHICH THE ADVANCED REGION OF INTEREST (ROI) EXPANSION TOOL EXPANDS ROIS INCORRECTLY ON HEADFIRST PRONE (HFP), FEET FIRST SUPINE (FFS), AND FEET FIRST PRONE (FFP) DATASETS. THERE IS NO ALLEGATION OF A DEATH OR SERIOUS INJURY. A DEFECT WAS FILED AND HAS BEEN EVALUATED BY THE DEFECT REVIEW BOARD (DRB) AND SCORED AS AN UNACCEPTABLE SAFETY DEFECT. AN ISSUE IMPACT ASSESSMENT (IIA) HAS BEEN TRIGGERED AND PHILIPS IS INVESTIGATING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20481113 ↗
• MalfunctionAug 24, 2022Program or Algorithm Execution Failure; Program or Algorithm Execution Failure

  THE DOSE FILE THAT WAS EXPORTED TO MIM AND TO MOBIUS FOR 3 PATIENT PLANS IS SHOWING A CALCULATED DOSE VALUE THAT IS DIFFERENT FROM WHAT IS IN PINNACLE 18.0.1. THIS BEHAVIOR WAS IDENTIFIED AT A CUSTOMER SITE AFTER THEY TRANSFERRED MULTIPLE PATIENT PLANS TO MOBIUS FOR PLAN QA PURPOSES. THE PLANS FAILED QA IN MOBIUS. UPON FURTHER INVESTIGATION THE USER DISCOVERED THAT THE DOSE INFORMATION EXPORTED OUT OF PINNACLE DID NOT MATCH THE DOSE IN THE PLANS IN PINNACLE. THIS ISSUE IS CURRENTLY UNDER INVESTIGATION BY THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15285745 ↗
• MalfunctionJun 30, 2022Program or Algorithm Execution Failure; Program or Algorithm Execution Failure

  EXPORTED DOSE FROM A PLAN IS WRONG WHEN IMPORTED BACK INTO PINNACLE AND WHEN EXPORTING TO 3RD PARTY SYSTEMS. THIS BEHAVIOR WAS IDENTIFIED BY THE CUSTOMER WHILE DOING DOSE COMPARISON TESTING BETWEEN SOFTWARE VERSION 18.0.1 AND SOFTWARE VERSION 9.8. AFTER EXPORTING PLANS TO 3RD PARTY SYSTEM MIM IT WAS DISCOVERED THAT THE DOSE WAS DIFFERENT BETWEEN THE TWO PLANS. THIS ISSUE IS CURRENTLY UNDER INVESTIGATION BY THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14875278 ↗