Zenition Zenition 50Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00884838091535), received between Sep 26, 2022 and Aug 21, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Radiation Output Failure” (19 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 16, 2026.

Recalls naming this device

1. Sep 29, 2025Open, Classified

   Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.

   Z-0241-2026 · Root cause: Process control · Recall details · FDA record ↗

2. 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-1580-2025 · Root cause: Labeling design · Recall details · FDA record ↗

3. Oct 7, 2024Open, Classified

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

   Z-0352-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S WIRELESS FOOTSWITCH WAS NOT WORKING 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 22862626 ↗
• MalfunctionAug 18, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S WIRELESS FOOTSWITCH WAS UNABLE TO CHARGE OR CONNECT, 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 22828144 ↗
• MalfunctionFeb 3, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH WAS NOT WORKING. 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 21291891 ↗
• MalfunctionNov 28, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S FOOTSWITCH WAS UNABLE TO TRIGGER X-RAYS, WHICH CAN IMPACT IMAGING. 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 20805757 ↗
• MalfunctionOct 7, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S WIRELESS FOOTSWITCH AND BASE STATION NEEDED TO BE REPLACED. 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 20383282 ↗
• MalfunctionSep 9, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT A PEDAL FROM THE SYSTEM'S FOOTSWITCH WAS NOT WORKING, WHICH CAN IMPACT IMAGING. NO HARM WAS REPORTED TO PHILIPS. THE DEVICE WAS OUTSIDE OF CLINICAL USE AT THE TIME OF REPORTED EVENT. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20169156 ↗
• MalfunctionJul 3, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH WAS NOT WORKING. NO USER OR PATIENT HARM WAS REPORTED TO PHILIPS. 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 19663663 ↗
• MalfunctionMay 16, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH LOST CONNECTION WITH THE WIRELESS BASE STATION. THE SYSTEM WAS NOT IN CLINICAL USE. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION REGARDING THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19335091 ↗
• MalfunctionMay 6, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE DEVICE'S FOOTSWITCH NEEDED TO BE REPLACED. THE DEVICE WAS OUTSIDE OF USE AT THE TIME OF REPORTED EVENT. 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 19247298 ↗
• MalfunctionMar 7, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE FOOT SWITCH WAS NOT WORKING. NO USER OR PATIENT HARM HAS BEEN REPORTED. WE ARE CONSERVATIVELY REPORTING THIS EVENT AS THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN FURTHER INFORMATION IS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18853889 ↗
• MalfunctionMar 6, 2024Radiation Output Failure; Radiation Output Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18845622 ↗
• MalfunctionJan 18, 2024Radiation Output Failure; Radiation Output Failure

  IT HAS BEEN REPORTED TO PHILIPS THAT THE DEFECTIVE FOOT SWITCHES REQUIRED REPLACEMENT. NO HARM HAS BEEN REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18537628 ↗
• MalfunctionNov 16, 2023Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE NEW FOOT SWITCH COULD NOT BE CONNECTED WIRELESSLY. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THE COMPLAINT.

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

  MAUDE report 18148310 ↗
• MalfunctionNov 1, 2023No Apparent Adverse Event; Radiation Output Failure; No Apparent Adverse Event; Radiation Output Failure

  IT HAS BEEN REPORTED TO PHILIPS THAT THE WIRELESS FOOT PEDAL WAS DEFECTIVE. THE DEVICE WAS IN CLINICAL USE. NO HARM HAS BEEN REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18048228 ↗
• MalfunctionAug 14, 2023Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE FOOTSWITCH WOULD INTERMITTENTLY FAIL. THE SYSTEM WAS IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. NO HARM WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN FURTHER INFORMATION IS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17539539 ↗
• MalfunctionMay 4, 2023Radiation Output Failure; Radiation Output Failure

  IT HAS BEEN REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH FAILED TO CONNECT TO THE SYSTEM. THE SYSTEM WAS IN CLINICAL USE WHEN THIS OCCURRED. THERE WAS NO REPORT OF HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16868223 ↗
• MalfunctionMar 23, 2023Radiation Output Failure; Radiation Output Failure

  IT HAS BEEN REPORTED TO PHILIPS THAT THE ZENITION 50 MOBILE SYSTEM FOOTSWITCH WAS NOT AVAILABLE. NO HARM HAS BEEN REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16601280 ↗
• MalfunctionMar 15, 2023Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH WAS NOT FUNCTIONING. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM WAS REPORTED. WE ARE CONSERVATIVELY REPORTING THIS EVENT AS THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN FURTHER INFORMATION IS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16543331 ↗
• MalfunctionOct 31, 2022Smoking; Smoking

  IT HAS BEEN REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO MAKE EXPOSURES AND SMOKE WAS SMELLED AND OBSERVED COMING FROM THE UNIT. NO HARM HAS BEEN REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15705385 ↗
• MalfunctionOct 7, 2022Radiation Output Failure; Radiation Output Failure

  IT HAS BEEN REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH HAS NOT BEEN WORKING SINCE INSTALLATION. A SYSTEM RESTART WAS PERFORMED TO RESET THE BASE STATION, HOWEVER THE CONNECTION HAS NOT BEEN RE-ESTABLISHED. NO HARM HAS BEEN REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15566684 ↗
• MalfunctionSep 26, 2022No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem

  THE SCREEN ON THE C-ARM STOPPED WORKING. THE SYSTEM WAS IN CLINICAL USE WHEN THIS OCCURRED. PHILIPS HAS STARTED THE INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15485004 ↗