Azurion Azurion 7 M12 (REF 722233)Recalls & reported problems
Philips Medical Systems Nederland B.V. · Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 12-inch flat detector. · Class 2
All models of Azurion (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
10 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
The Azurion 7 is a Philips ceiling- or floor-mounted X-ray system used for image-guided procedures, with a 12-inch flat detector. Its 29 reports mostly describe the system failing to produce X-rays or images, freezing or restarting, and moving on its own or failing to position. No deaths or injuries are reported. Ten recalls are open, covering software faults that cause lost imaging or unintended table movement, a foot switch that may not start imaging, loosening monitor suspension parts, and a finger-entrapment and patient fall risk on the patient table.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 10
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00884838116764), received between Dec 27, 2024 and May 14, 2026 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Radiation Output Failure” (13 reports).
10 FDA recall records name this device's identifier, 10 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.
Reports received per month
Recalls naming this device
- Jul 16, 2026Class IIOpen, Classified
Two software related issues affecting Philips Azurion R3.0 and R3.1 systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications.
Z-2932-2026 · Root cause: Software design · Recall details · FDA record ↗
- Apr 28, 2026Class IIOpen, Classified
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.
Z-2225-2026 · Root cause: Device Design · Recall details · FDA record ↗
- Mar 31, 2026Class IIOpen, Classified
Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated.
Z-2170-2026 · Root cause: Device Design · Recall details · FDA record ↗
- Mar 3, 2026Class IIOpen, Classified
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Z-1677-2026 · Root cause: Device Design · Recall details · FDA record ↗
- Jan 26, 2026Class IIOpen, Classified
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Z-1348-2026 · Root cause: Device Design · Recall details · FDA record ↗
- Dec 12, 2025Class IIOpen, Classified
Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error Applicable only to systems with Poly-G3 frontal stand.
Z-1113-2026 · Root cause: Software design · Recall details · FDA record ↗
- Dec 8, 2025Class IIOpen, Classified
Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.
Z-1079-2026 · Root cause: Software design · Recall details · FDA record ↗
- Jan 13, 2025Class IOpen, Classified
Possibility of the patient falling from the table related to the mattress used on the patient table.
Z-1159-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jan 13, 2025Class IIOpen, Classified
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
Z-1093-2025 · Root cause: Device Design · Recall details · FDA record ↗
- Aug 22, 2024Class IIOpen, Classified
Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
Z-3165-2024 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Radiation Output Failure13
- Activation Failure4
- Positioning Failure4
- No Display/Image3
- Detachment of Device or Device Component2
- Unintended System Motion1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2026Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO PRODUCE X-RAYS. THE SYSTEM 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 25175288 ↗MalfunctionApr 1, 2026Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM DISPLAYED AN ALERT THAT THE BEAMS WERE OFF, WHICH COULD 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 24757320 ↗MalfunctionMar 25, 2026Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT SYSTEM'S WIRED FOOTSWITCH WAS NOT WORKING, WHICH CAN IMPACT IMAGING. 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 24693967 ↗MalfunctionMar 25, 2026Activation Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM SHUT DOWN TWICE DURING THE PROCEDURE AND EXPERIENCED AN UNSPECIFIED DELAY IN BOOTING BACK UP. THE DEVICE WAS IN 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 24686368 ↗MalfunctionMar 20, 2026Activation Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE AN ALERT INDICATING THE SUITE COMPUTER'S SOFTWARE CRASHED, PREVENTING A FULL SYSTEM BOOT. THE DEVICE WAS IN 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 24647261 ↗MalfunctionFeb 20, 2026No Display/Image
IT WAS REPORTED TO PHILIPS THAT ALL MONITORS WERE UNABLE TO DISPLAY IMAGES. THE SYSTEM WAS RESTARTED BUT THE ISSUE PERSISTED. THE SYSTEM 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 24401909 ↗MalfunctionFeb 11, 2026Unintended System Motion
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S C-ARM PERFORMED AN UNCOMMANDED MOVEMENT. 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 24311632 ↗MalfunctionFeb 3, 2026Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S WIRELESS FOOTSWITCH WAS NOT WORKING, 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 24243248 ↗MalfunctionJan 21, 2026Radiation Output Failure
IT HAS BEEN REPORTED TO PHILIPS THAT THE SYSTEM COULD NOT ACCESS X-RAY GENERATOR, WHICH CAN IMPACT IMAGING. THE DEVICE WAS IN 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 24131334 ↗MalfunctionJan 5, 2026Positioning Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE AN ALERT INDICATING SOME STAND MOVEMENTS WERE NOT AVAILABLE, WHICH CAN IMPACT GEOMETRY. 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 23960395 ↗MalfunctionDec 3, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE AN ALERT THAT GEOMETRY MOVEMENTS WERE NOT AVAILABLE. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23702512 ↗MalfunctionNov 19, 2025Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO PRODUCE X-RAYS. 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 23592618 ↗MalfunctionNov 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO PHILIPS THAT THE LOWER SCREW OF THE BANANA COVER HAD FALLEN INTO THE STERILE AREA, WHICH CAN IMPACT PATIENT. THE DEVICE WAS IN 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 23531496 ↗MalfunctionOct 16, 2025No Display/Image; No Display/Image
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S FLEXVISION MONITOR SHUT DOWN, WHICH IMPACTED IMAGING DISPLAYS. THE DEVICE WAS IN 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 23311359 ↗MalfunctionOct 16, 2025Activation Failure; Activation Failure
IT WAS REPORTED TO PHILIPS THAT THE VIDEO CAPTURE CARD WAS UNABLE TO INITIALIZE, WHICH CAN IMPACT THE FULL SYSTEM BOOT. 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 23310004 ↗MalfunctionOct 15, 2025Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM HAD CRASHED, PREVENTING X-RAYS. 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 23298947 ↗MalfunctionSep 18, 2025Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO ACQUIRE X-RAYS AFTER POWER OUTAGE. THE CUSTOMER RESTARTED THE SYSTEM BUT THE SCREEN REMAINED BLACK. 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 23089226 ↗MalfunctionSep 15, 2025No Display/Image; No Display/Image
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S MONITOR FAILED TO DISPLAY IMAGES. THE DEVICE WAS IN USE AT THE TIME OF 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 23052901 ↗MalfunctionSep 11, 2025Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS INTERMITTENTLY HANGING, WHICH IMPACTED IMAGING AND DISPLAY. 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 23027847 ↗MalfunctionSep 5, 2025Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO PRODUCE X-RAYS. THE DEVICE WAS IN 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 22983572 ↗MalfunctionJul 26, 2025Activation Failure; Activation Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT UP. THE DEVICE WAS NOT 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 22621432 ↗MalfunctionJul 17, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED TO PHILIPS THAT THE GEOMETRY MOVEMENTS OF THE C-ARM WERE PARTIALLY UNAVAILABLE. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22531036 ↗MalfunctionJul 7, 2025Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM DISPLAYED A COLLIMATOR ERROR, WHICH COULD IMPACT IMAGING. 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 22409453 ↗MalfunctionJun 11, 2025Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS INTERMITTENTLY UNABLE TO PERFORM IMAGING. THE DEVICE WAS IN 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 22190227 ↗MalfunctionJun 3, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED TO PHILIPS THAT THE GEOMETRY MOVEMENTS WERE NOT WORKING AND AN ERROR MESSAGE WAS DISPLAYED. 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 22129543 ↗
Other Interventional fluoroscopic x-ray system devices
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- O-ARM® BI70002000Medtronic Navigation, Inc. · Interventional fluoroscopic x-ray system2 recalls1 death3,667 reports
- Azurion Azurion 7 M20Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System28 recalls1 death2,176 reports
- Allura Xper FD Allura Xper FD10Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System23 recalls2 deaths2,015 reports
- Allura Xper FD Allura Xper FD10Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System20 recalls2 deaths1,837 reports
- Azurion Azurion 7 M12Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System24 recalls2 deaths1,087 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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