Zenition Zenition 70Recalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 00884838091528), received between Dec 13, 2021 and Mar 24, 2026 — classified as 1 injury, 79 malfunctions.

The most frequently reported specific device problem is “Radiation Output Failure” (75 reports).

2 FDA recall records name this device's identifier, 2 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 16, 2026.

Recalls naming this device

1. Feb 25, 2025Open, Classified

   A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.

   Z-1581-2025 · Root cause: Labeling design · Recall details · FDA record ↗

2. Oct 7, 2024Open, Classified

   Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.

   Z-0353-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Unexpected Shutdown

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM DISPLAYED A BATTERY ERROR AND POWERED OFF NEAR THE END OF A LOWER EXTREMITY ARTERIOGRAM WITH INTERVENTION (THROMBECTOMY) PROCEDURE, DURING WHICH THE PATIENT WAS SEDATED, AND ARTERIAL ACCESS HAD BEEN ESTABLISHED. ACCORDING TO THE REPORT, THE PATIENT EXPERIENCED A THROMBOEMBOLIC EVENT AND WAS TRANSFERRED TO A HOSPITAL, WHERE THEY RECEIVED HEPARIN ANTICOAGULATION. THE CUSTOMER NOTED THAT THE PATIENT¿S FOOT IS NOW STABLE AND THAT NO LASTING CLINICAL CONSEQUENCES WERE OBSERVED. AN INVESTIGATION INTO THIS COMPLAINT HAS BEEN INITIATED BY PHILIPS.

  Patient problems: Thromboembolism

  MAUDE report 24675348 ↗
• MalfunctionOct 21, 2025Smoking; Smoking

  IT WAS REPORTED TO PHILIPS THAT THE ELECTRONIC COMPONENTS OF THE X-RAY GENERATOR WERE BURNT, WHICH WAS CAUSING THE SYSTEM TO PRODUCE VISIBLE SMOKE. THE DEVICE WAS OUTSIDE OF CLINICAL USE AT THE TIME OF REPORTED EVENT. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347589 ↗
• MalfunctionJun 10, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S WIRELESS FOOTSWITCH WAS DEFECTIVE, WHICH CAN IMPACT IMAGING. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176441 ↗
• MalfunctionApr 24, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S FOOTSWITCH HAD A PROBLEM, WHICH CAN IMPACT IMAGING. NO HARM WAS REPORTED TO PHILIPS. WE ARE CONSERVATIVELY REPORTING THIS EVENT AS THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900138 ↗
• MalfunctionFeb 18, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH HAD A CONNECTION PROBLEM. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21400712 ↗
• MalfunctionJan 28, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S WIRELESS FOOTSWITCH WAS DEFECTIVE. NO HARM WAS REPORTED TO PHILIPS. WE ARE CONSERVATIVELY REPORTING THIS EVENT AS THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252225 ↗
• MalfunctionJan 13, 2025Radiation Output Failure; Radiation Output Failure

  IT HAS BEEN REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH DID NOT CHARGE. THE SYSTEM WAS IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. THERE WAS NO REPORTED PATIENT OR USER HARM. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143531 ↗
• MalfunctionJan 13, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S WIRELESS FOOTSWITCH AND BASE STATION WAS DEFECTIVE. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21142446 ↗
• MalfunctionJan 7, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOT SWITCH LOST CONNECTION AS THE WI-FI INDICATOR LED STAYED RED. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091101 ↗
• MalfunctionDec 9, 2024Radiation Output Failure; Radiation Output Failure

  IT HAS BEEN REPORTED TO PHILIPS THAT THERE WAS A PROBLEM WITH THE FOOTSWITCH. THERE WAS NO REPORTED PATIENT OR USER HARM. DUE TO THE LACK OF INFORMATION, WE ARE CONSERVATIVELY REPORTING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878957 ↗
• MalfunctionNov 25, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH WOULD NOT CONNECT. 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 20773900 ↗
• MalfunctionNov 18, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOT SWITCH (WFS) WAS UNABLE TO CONNECT TO THE SYSTEM. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20704099 ↗
• MalfunctionNov 7, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT CUSTOMER REQUESTED A REPLACEMENT WIRELESS FOOTSWITCH. NO HARM WAS REPORTED TO PHILIPS. WE ARE CONSERVATIVELY REPORTING THIS EVENT AS THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20629476 ↗
• MalfunctionOct 21, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH WAS DEFECTIVE. NO HARM WAS REPORTED TO PHILIPS. WE ARE CONSERVATIVELY REPORTING THIS EVENT AS THE INVESTIGATION IS ONGOING.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20492161 ↗
• MalfunctionOct 9, 2024Radiation Output Failure; Radiation Output Failure

  IT HAS BEEN REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH LOST CONNECTION TO THE SYSTEM. THE SYSTEM WAS IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. THE CUSTOMER CONNECTED A WIRED FOOTSWITCH TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT OR USER HARM. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409469 ↗
• MalfunctionSep 25, 2024Radiation Output Failure; Radiation Output Failure

  IT HAS BEEN REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH INTERMITTENTLY LOST CONNECTION WITH THE SYSTEM. THE SYSTEM WAS NOT IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. THERE WAS NO REPORTED PATIENT OR USER HARM. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305348 ↗
• MalfunctionSep 13, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH HAD A CONNECTION ISSUE. THE SYSTEM WAS IN CLINICAL SUE AT THE TIME OF THE REPORTED EVENT. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20212086 ↗
• MalfunctionSep 9, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THERE WAS A PROBLEM WITH THE FOOT SWITCH PEDAL. THE DEVICE WAS OUTSIDE OF CLINICAL USE AT THE TIME OF THE EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED. WE ARE CONSERVATIVELY REPORTING THIS EVENT AS THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20169037 ↗
• MalfunctionAug 27, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH WAS DEFECTIVE. NO HARM WAS REPORTED TO PHILIPS. WE ARE CONSERVATIVELY REPORTING THIS EVENT AS THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN FURTHER INFORMATION IS RECEIVED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20076738 ↗
• MalfunctionAug 21, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH WAS NOT WORKING. THE DEVICE WAS OUTSIDE OF CLINICAL USE AT THE TIME OF THE REPORTED EVENT. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20011123 ↗
• MalfunctionAug 15, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT DURING A PROCEDURE THE SYSTEM PRODUCED RE-OCCURRING "MA GUARDING FAILURE" ERROR MESSAGES. THE PROCEDURE WAS DELAYED WHILE THE CUSTOMER ATTEMPTED TO RESTART THE SYSTEM. AFTER THE THIRD ATTEMPT, THE CUSTOMER BROUGHT IN A DIFFERENT SYSTEM TO COMPLETE THE PROCEDURE. THE REPORT INDICATED THAT THERE WAS A SERIOUS INJURY; HOWEVER, NO FURTHER INFORMATION REGARDING THE HARM HAS BEEN PROVIDED TO DATE. AN INVESTIGATION INTO THIS COMPLAINT HAS BEEN INITIATED BY PHILIPS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990607 ↗
• MalfunctionJul 19, 2024Adverse Event Without Identified Device or Use Problem; Radiation Output Failure; Adverse Event Without Identified Device or Use Problem; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT DURING A FLUOROSCOPY EXAMINATION, THE SYSTEM LOST FUNCTIONALITY. THE CUSTOMER REBOOTED THE SYSTEM MULTIPLE TIMES WITHOUT RESOLVING THE ISSUE. THE PATIENT WAS LATER MOVED TO ANOTHER ROOM TO COMPLETE THE PROCEDURE. IT WAS REPORTED TO PHILIPS THAT THE DELAY IN COMPLETION OF THE MEDICAL PROCEDURE MAY HAVE CONTRIBUTED TO THE POOR OUTCOME OF THE ENTIRE PROCEDURE; HOWEVER, NO FURTHER DETAILS HAVE BEEN PROVIDED AS OF THE DATE OF THIS INITIAL REPORT. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: Insufficient Information; Loss of consciousness; Unspecified Gastrointestinal Problem

  MAUDE report 19780343 ↗
• MalfunctionJul 1, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH WAS DEFECTIVE. NO USER OR PATIENT HARM HAS BEEN REPORTED. TO DATE, NO FURTHER INFORMATION WAS RECEIVED. WE ARE CONSERVATIVELY REPORTING THIS EVENT AS THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN FURTHER INFORMATION IS RECEIVED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19641701 ↗
• MalfunctionJun 6, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH HAD A CONNECTION ISSUE. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE REPORTED 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 19475207 ↗
• MalfunctionJun 3, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE DEVICE'S WIRELESS FOOTSWITCH WAS INOPERATIVE. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED. WE ARE CONSERVATIVELY REPORTING THIS EVENT AS THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19446973 ↗