Philips 459801419352Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00884838091122), received between Aug 31, 2018 and May 7, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (2 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 16, 2026.

Recalls naming this device

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 ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2024Application Program Problem; Application Program Problem

  IT WAS REPORTED TO PHILIPS THAT INCORRECT IMAGE DATA WAS USED TO CREATE A TREATMENT PLAN. WHEN EXPORTING THE TREATMENT PLAN THE ONCOLOGY INFORMATION SYSTEM (OIS) WARNED THE USER THE IMAGES WERE ALREADY IN USE BY A DIFFERENT PATIENT. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19258943 ↗
• MalfunctionAug 14, 2020Application Program Problem

  THE CUSTOMER WAS ATTEMPTING TO SAVE A CONFORMAL ARC PLAN HOWEVER THE PINNACLE SOFTWARE WOULD CRASH AFTER EACH ATTEMPT. THERE WAS NO PATIENT IMPACT AS THE INABILITY TO SAVE THE PLAN WOULD PREVENT THE PLAN FROM BEING USED. A REMOTE-IN SESSION AND REVIEW OF PLAN LOGS REVEALED A FAILED ASSERTION IN THE SOFTWARE FOR ONE OF THE CONTROL POINTS. PHILIPS HAS DETERMINED THIS TO BE A KNOWN ISSUE THAT CAN OCCUR WHEN THE GANTRY STOP ANGLE IS CHANGED IN THE BEAM SPREADSHEET, WHERE THE MACHINE LIMITS ARE NOT CHECKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10406848 ↗
• MalfunctionJul 8, 2020Failure to Deliver

  THE CUSTOMER HAS A VMAT PLAN THAT WON'T DELIVER ON THE MACHINE. NO PATIENT IMPACT. INSPECTION SHOWS THAT ONE OF THE ARCS CROSSES THE 180 DEGREE (I.E. PA) POSITION. SUPPORT HAS DETERMINED THAT THIS IS A KNOWN ISSUE THAT CAN OCCUR WHEN THE GANTRY STOP ANGLE IS CHANGED IN THE BEAM SPREADSHEET, WHERE THE MACHINE LIMITS ARE NOT CHECKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10246031 ↗
• MalfunctionOct 22, 2019Improper or Incorrect Procedure or Method

  A CUSTOMER CONTACTED PHILIPS TO ADVISE THAT A USER ERROR CAUSED INACCURATE TREATMENT DOSES TO BE ADMINISTERED TO A PATIENT. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9219170 ↗
• MalfunctionSep 25, 2019Application Program Problem: Dose Calculation Error

  PINNACLE COMPUTES THE DOSE AT 131 DEGREES AND 90 DEGREES, AND NOTHING IN BETWEEN. HALF OF CP 17¿S DOSE IS AT 131, AND THE OTHER HALF IS AT 90, AND NOTHING IN BETWEEN IS INCLUDED. THE DOSE IS NOT SPREAD OUT BETWEEN 131 AND 90.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9120714 ↗
• MalfunctionNov 23, 2018Appropriate Device Problem Term/Code Not Available

  THE WEDGE ID IS NOT EXPORTED VIA DICOM UNLESS MANUFACTURE CODE IS POPULATED IN PHYSICS (300A,00D4). INITIAL INVESTIGATION RESULTED IN THE REALIZATION THAT THERE WAS NO MANUFACTURE CODE FOR THE EDW WEDGE IN PHYSICS. THIS RESULTED IN NO WEDGE ID BEING EXPORTED VIA DICOM TO THE R&V SYSTEM.

  Patient problems: No Information

  MAUDE report 8100110 ↗
• MalfunctionSep 27, 2018Protective Measures Problem

  THE PROBLEM IS THAT THE DENSITY OVERRIDE AS REPORTED IN THE REGIONS OF INTEREST WINDOW IS DIFFERENT FROM THE DENSITY THAT IS ACTUALLY USED FOR DOSE CALCULATION IN THE PLAN, ONLY OCCURS WHEN THERE IS A PROTON LICENSE ON THE SYSTEM. WHEN THERE IS NO PROTON LICENSE THIS DOES NOT OCCUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7915791 ↗
• MalfunctionAug 31, 2018Defective Component

  ON AUGUST 2, 2018 WE RECEIVED A COMPLAINT, FROM (B)(6) MEDICAL CENTER, STATING THAT THE COUCH REMOVAL PLAN MOVES FROM THE POSITION SELECTED BY THE USER. THE CUSTOMER ALLEGED THIS IS TO BE A SAFETY ISSUE. THIS SITUATION WAS DETERMINED TO BE THE SAME AS PINN00027109 (A KNOWN NON-SAFETY RELATED DEFECT FROM A COMPLAINT MADE BY (B)(6) CANCER CENTER ON (B)(6) 2017). BASED ON THE ALLEGATION OF A SAFETY ISSUE BY UH CLEVELAND MEDICAL CENTER AND RECOMMENDATION OF PHILIPS APPLICATION SUPPORT ENGINEERS, A SPECIAL DEFECT MANAGEMENT COMMITTEE MEETING WAS HELD TO DISCUSS DEFECT PINN00027109 (A KNOWN DEFECT FROM A COMPLAINT MADE BY (B)(6) CANCER CENTER ON (B)(6) 2017). DURING THIS MEETING, BASED ON NEW INFORMATION, FROM THE UH CLEVELAND MEDICAL CENTER COMPLAINT CALL AND INVESTIGATION IT WAS DECIDED THAT THE DEFECT SEVERITY SHOULD BE CHANGED FROM SEVERITY 4 TO SEVERITY 3. IN THIS INSTANCE, THE SEVERITY 3 IS A SAFETY-RELATED SEVERITY 3; THIS IS NOT A SEVERITY 3 DUE TO A LACK OF A WORK-AROUND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7839397 ↗

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-2239-2025 · Jul 17, 2025 · Open, Classified
  Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
• Z-1744-2022 · Aug 30, 2022 · Open, Classified
  Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.