Veradius Veradius UnityRecalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00884838058194), received between Jan 12, 2022 and Jun 9, 2025 — classified as 1 injury, 54 malfunctions.

The most frequently reported specific device problem is “Radiation Output Failure” (52 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. How this data works · Data updated Oct 13, 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-1582-2025 · Root cause: Labeling design · FDA record ↗

2. Nov 12, 2021Open, Classified

   Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns

   Z-0357-2022 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S WIRELESS FOOTSWITCH BATTERY WAS OUT OF SERVICE, 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 22172462 ↗
• MalfunctionApr 4, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOT SWITCH WAS NOT WORKING. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21771253 ↗
• MalfunctionApr 4, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOT SWITCH WAS NOT WORKING. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21771252 ↗
• MalfunctionFeb 25, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S FOOTSWITCH CHARGER WAS UNABLE TO CHARGE. THE DEVICE WAS OUTSIDE OF 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 21459624 ↗
• MalfunctionFeb 7, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S FOOTSWITCH WAS UNABLE TO CONNECT WIRELESSLY. THE SYSTEM WAS NOT IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM WAS REPORTED TO PHILIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21334070 ↗
• MalfunctionJan 23, 2025Electrical Overstress; Electrical Overstress

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM REFERENCE MONITOR WAS EMITTING SMOKE. THE DEVICE WAS OUTSIDE CLINICAL USE AT THE TIME OF THE EVENT. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLIANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219263 ↗
• MalfunctionJan 14, 2025Radiation Output Failure; Radiation Output Failure

  IT HAS BEEN REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH 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 21149499 ↗
• MalfunctionOct 8, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH DOES NOT WORK. 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 20394841 ↗
• MalfunctionAug 26, 2024Radiation Output Failure; Radiation Output Failure

  IT HAS BEEN REPORTED TO PHILIPS THAT DURING AN OPEN REDUCTION AND INTERNAL FIXATION SURGERY OF A FRACTURED HUMERUS, THE FOOT SWITCH DID NOT TRIGGER EXPOSURES. THE SYSTEM WAS REBOOTED WITH RESOLVE. 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 20069510 ↗
• MalfunctionJun 14, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOT SWITCH STOPPED WORKING. THE SYSTEM WAS IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19534984 ↗
• MalfunctionJun 7, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE DEVICE'S WIRELESS FOOTSWITCH WAS NOT CONNECTING/PAIRING. THE SYSTEM WAS IN CLINICAL USE. NO USER OR PATIENT HARM HAS BEEN REPORTED. A PHILIPS FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND PERFORMED THE PAIRING ACTION AGAIN. THE DEVICE WAS RETURNED TO EXPECTED FUNCTIONALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19491394 ↗
• MalfunctionMay 9, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOT SWITCH LOST ITS CONNECTION. THE SYSTEM WAS IN CLINICAL USE. NO USER OR PATIENT HARM HAS BEEN REPORTED.A PHILIPS FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND REPLACED THE WIRELESS FOOT SWITCH. THE DEVICE WAS RETURNED TO EXPECTED FUNCTIONALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19277065 ↗
• MalfunctionMay 6, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH WAS NOT WORKING. THERE WAS NO REPORTED PATIENT OR USER HARM. DUE TO THE LACK OF INFORMATION, WE ARE CONSERVATIVELY REPORTING THIS EVENT. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19248333 ↗
• MalfunctionMay 2, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOT SWITCH WAS NOT WORKING. THE SYSTEM WAS IN CLINICAL USE. NO USER OR PATIENT HARM WAS REPORTED. A PHILIPS FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND REPLACED THE WIRELESS FOOT SWITCH BASE STATION AND WAS ABLE TO PAIR WITH THE WIRELESS FOOT SWITCH. THE DEVICE WAS RETURNED TO EXPECTED FUNCTIONALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19229262 ↗
• MalfunctionMay 2, 2024Smoking; Smoking

  IT WAS REPORTED TO PHILIPS THAT THE DEVICE WAS MAKING A SPARKING NOISE AND SMOKE WAS COMING OUT. 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 19229119 ↗
• MalfunctionMar 7, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH BASE STATION WAS DEFECTIVE. THE SYSTEM WAS NOT IN CLINICAL USE. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18855270 ↗
• MalfunctionMar 6, 2024Radiation Output Failure; Radiation Output Failure

  IT HAS BEEN REPORTED TO PHILIPS THAT THE SYSTEM WAS HAVING PROBLEMS WITH THE WIRELESS FOOTSWITCH. THE DEVICE WAS OUTSIDE CLINICAL USE AT THE TIME OF THE REPORTED EVENT. NO HARM HAS BEEN REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION INTO THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18849773 ↗
• MalfunctionMar 5, 2024Radiation Output Failure; Radiation Output Failure

  IT HAS BEEN REPORTED TO PHILIPS THAT SYSTEM WIRELESS FOOTSWITCH WAS NOT WORKING. THE DEVICE WAS OUTSIDE CLINICAL USE AT THE TIME OF THE REPORTED EVENT. 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 18835721 ↗
• MalfunctionFeb 23, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOT SWITCH LOST THE WIRELESS CONNECTION WITH THE BASE STATION. NO USER OR PATIENT HARM HAS BEEN REPORTED. PHILIPS HAS STARTED AN INVESTIGATION REGARDING THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18767975 ↗
• MalfunctionFeb 23, 2024Radiation Output Failure; Radiation Output Failure

  IT HAS BEEN REPORTED TO PHILIPS THAT WIRELESS FOOT SWITCH WAS DEFECTIVE. THE SYSTEM WAS NOT IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. THERE WAS NO HARM REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18767551 ↗
• MalfunctionFeb 7, 2024Radiation Output Failure; Radiation Output Failure

  IT HAS BEEN REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH WAS DEFECTIVE. 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 18657223 ↗
• MalfunctionFeb 6, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT FLUOROSCOPY WAS NOT POSSIBLE WHEN PRESSING THE WIRELESS FOOT PEDAL. NO HARM WAS REPORTED TO PHILIPS. THE DEVICE WAS IN 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 18654903 ↗
• MalfunctionFeb 6, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOT SWITCH WAS NOT WORKING. NO USER OR PATIENT HARM HAS BEEN REPORTED. PHILIPS HAS STARTED AN INVESTIGATION REGARDING THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18648843 ↗
• MalfunctionFeb 6, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOT SWITCH WAS NOT WORKING. NO USER OR PATIENT HARM HAS BEEN REPORTED. PHILIPS HAS STARTED AN INVESTIGATION REGARDING THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18648810 ↗
• MalfunctionFeb 2, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT IT WAS NOT POSSIBLE TO COMMUNICATE WITH THE WIRELESS FOOT SWITCH. THE SYSTEM WAS NOT IN CLINICAL USE. NO USER OR PATIENT HARM HAS BEEN REPORTED. PHILIPS HAS STARTED AN INVESTIGATION REGARDING THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18630083 ↗