Pinnacle Radiation Therapy Planning System 16.4Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884838102965), received between Jun 28, 2022 and Jun 30, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Program or Algorithm Execution Failure” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K170086); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170086. One submission often covers many models, so check the product and lot details in each record.

• Z-2570-2025 · Aug 5, 2025 · Open, Classified
  Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Pinnacle TumorLOC 16.2 Model 87022
• Z-2239-2025 · Jul 17, 2025 · Open, Classified
  Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software