Pinnacle Radiation Therapy Planning SystemRecalls & reported problems across all models

We found 2 models of Pinnacle Radiation Therapy Planning System by Philips Medical Systems (cleveland), Inc. in the FDA's device registry (GUDID). Together they are named in 7 adverse event reports in the FDA's MAUDE database, received between Jun 28, 2022 and Oct 18, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Program or Algorithm Execution Failure” (5 reports).

3 FDA recall records name at least one of these models by its device 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. 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

Pinnacle Radiation Therapy Planning System 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. Aug 5, 2025Open, 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, 2025Open, 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, 2022Open, 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 · names 2 of these models · Recall details · FDA record ↗

Most reported Pinnacle Radiation Therapy Planning System problems

Pinnacle Radiation Therapy Planning System models

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

• Pinnacle Radiation Therapy Planning System 18.0

  System, planning, radiation therapy treatment
  3 recalls4 reports
• Pinnacle Radiation Therapy Planning System 16.4

  System, planning, radiation therapy treatment
  1 recall3 reports

Recent Pinnacle Radiation Therapy Planning System adverse event reports

The 7 most recent reports across all models, 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

  DOSE EXPORTED TO 3RD PARTY SYSTEMS IS DIFFERENT THAN WHAT IS IN PINNACLE 16.4.3 THIS BEHAVIOR WAS IDENTIFIED AT A CUSTOMER SITE AFTER THEY SUBMITTED A TREATMENT PLAN FOR INCLUSION IN A TRIAL. THE TREATMENT PLAN WAS REJECTED BY THE TRIAL BECAUSE IT DID NOT MEET DOSE REQUIREMENTS. UPON FURTHER INVESTIGATION THE USER DISCOVERED THAT THE DOSE INFORMATION EXPORTED OUT OF PINNACLE DID NOT MATCH THE DOSE IN THE PLAN IN PINNACLE. THIS ISSUE IS CURRENTLY UNDER INVESTIGATION BY THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14875409 ↗
• MalfunctionJun 30, 2022Program or Algorithm Execution Failure; Program or Algorithm Execution Failure

  IT WAS REPORTED THAT THE HAD DRIVELINE POWER FAULT ALARMS. THE PUMP WAS RUNNING FINE AND THE PATIENT WAS DOING WELL. A REVIEW OF THE LOG FILES BY TECHNICAL SERVICES FOUND INTERMITTENT DRIVELINE POWER FAULT ALARMS FROM (B)(6) 2022 - (B)(6) 2022. THE PATIENT'S SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED. THE DRIVELINE POWER FAULT ALARM HAD CLEARED AND HAD NOT RETURNED. THERE WAS NO ADVERSE PATIENT IMPACT. RELATED MFR #2916596-2022-12006.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14875337 ↗
• 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 ↗
• MalfunctionJun 28, 2022Program or Algorithm Execution Failure; Program or Algorithm Execution Failure

  IMPORTED DOSE IS DIFFERENT THAN PLAN DOSE IN SPECIFIC SCENARIO 16.4.3. THIS HAS BEEN IDENTIFIED AT A CUSTOMER SITE DURING IN-HOUSE ACCEPTANCE TESTING OF PINNACLE 16.4.3 PRIOR TO MOVING TO CLINICAL USE OF THE SOFTWARE. DURING THE DOSE COMPUTATION STAGE, THE USER COMPUTED A RADIATION DOSE WITH THE DOSE PRESCRIPTION SET TO ¿PERCENTAGE OF POINT DOSE,¿ AND THE BEAM WEIGHTS PROPORTIONAL TO POINT DOSE WHICH RESULTED IN THE RADIATION THERAPY (RT) DOSE INFORMATION IN DICOM (DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE) FORMAT, BEING EXPORTED INCORRECTLY INTO THIRD PARTY SYSTEMS AS WELL AS INTO PINNACLE ITSELF. THE INCORRECT EXPORTED DOSE INFORMATION CAN THEN BE USED FOR FUTURE TREATMENT PLANNING IF A PATIENT NEEDS ADDITIONAL TREATMENT. THIS ISSUE IS CURRENTLY UNDER INVESTIGATION BY THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14843237 ↗