ZenitionRecalls & reported problems across all models
Philips Medical Systems Nederland B.V. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
5 open recalls name at least one Zenition model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 101
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 5
We found 2 models of Zenition by Philips Medical Systems Nederland B.V. in the FDA's device registry (GUDID). Together they are named in 101 adverse event reports in the FDA's MAUDE database, received between Dec 13, 2021 and Mar 24, 2026 — classified as 1 injury, 100 malfunctions.
The most frequently reported specific device problem is “Radiation Output Failure” (94 reports).
5 FDA recall records name at least one of these models by its device identifier, 5 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Zenition recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 29, 2025Class IIOpen, 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 ↗
- Feb 25, 2025Class IIOpen, 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 ↗
- Feb 25, 2025Class IIOpen, 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 ↗
- Oct 7, 2024Class IIOpen, 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 ↗
- Oct 7, 2024Class IIOpen, 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 Zenition problems
Device problems
- Radiation Output Failure94
- Smoking3
- Activation Failure2
- Adverse Event Without Identified Device or Use Problem1
- Device Handling Problem1
- Display or Visual Feedback Problem1
- Insufficient Device Problem Information1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions98
- Insufficient Information4
- Loss of consciousness1
- Swelling/ Edema1
- Thromboembolism1
- Unspecified Gastrointestinal Problem1
Zenition models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Zenition Zenition 70Image-Intensified Fluoroscopic X-Ray System, Mobile2 recalls80 reports
- Zenition Zenition 50Image-Intensified Fluoroscopic X-Ray System, Mobile3 recalls21 reports
Recent Zenition adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗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 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 ↗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 ↗
Other Philips Medical Systems Nederland B.V. products
- Allura Xper FD19 models · 15,187 reports · 84 recalls
- Azurion22 models · 9,199 reports · 71 recalls
- Ingenia54 models · 479 reports · 138 recalls
- IntelliSpace Cardiovascular11 models · 439 reports · 3 recalls
- MR 7000 Series2 models · 4 reports · 11 recalls
- Dynamic Coronary Roadmap3 models · 10 reports · 9 recalls
- MR 5000 Series3 models · 11 reports · 8 recalls
- Brilliance iCT2 models · 9 reports · 8 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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