Allura Xper FD Allura Xper FD20 OR Table (REF 722023)Recalls & reported problems
Philips Medical Systems Nederland B.V. · Monoplane Interventional X-Ray System. A ceiling-mounted monoplane system with a 20-inch flat detector and interface for an OR table · Class 2
All models of Allura Xper FD (19)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
15 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Philips Allura Xper is a ceiling-mounted X-ray imaging system. Reports most often describe the system failing to activate, lose radiation output, or show no image. The database holds 245 malfunction reports, with no deaths and no injuries. There are 15 open recalls, covering issues such as hard drives, cooling hoses, foot switches and a mattress that may let a patient fall. Reports fell over the last year (14) compared with the year before (79).
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
- 246
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 15
Summary
The FDA's MAUDE database contains 246 adverse event reports that list this exact device (DI 00884838059085), received between May 25, 2021 and Sep 29, 2026 — classified as 246 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (103 reports).
15 FDA recall records name this device's identifier, 15 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 18, 2026.
Reports received per month
Recalls naming this device
- Jun 17, 2026Class IIOpen, Classified
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Z-2891-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Apr 30, 2026Class IIOpen, Classified
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.
Z-2259-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Apr 28, 2026Class IIOpen, Classified
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.
Z-2228-2026 · Root cause: Component design/selection · 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-1665-2026 · Root cause: Device Design · Recall details · FDA record ↗
- Dec 15, 2025Class IIOpen, Classified
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Z-1072-2026 · Root cause: Other · Recall details · FDA record ↗
- Sep 3, 2025Class IIOpen, Classified
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
Z-2628-2025 · Root cause: Device Design · Recall details · FDA record ↗
- Sep 3, 2025Class IIOpen, Classified
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
Z-0008-2026 · Root cause: Device Design · Recall details · FDA record ↗
- Aug 1, 2025Class IIOpen, Classified
Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.
Z-2503-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Aug 1, 2025Class IIOpen, Classified
Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.
Z-2504-2025 · Root cause: Under Investigation by firm · 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-1147-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jan 2, 2024Class IIOpen, Classified
Dual In-Line Memory Modules (DIMMs) may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
Z-1156-2024 · Root cause: Process design · Recall details · FDA record ↗
- Jan 2, 2024Class IIOpen, Classified
Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure.
Z-1144-2024 · Root cause: Process design · Recall details · FDA record ↗
- Jan 2, 2024Class IIOpen, Classified
Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
Z-1151-2024 · Root cause: Process design · Recall details · FDA record ↗
- Nov 3, 2023Class IIOpen, Classified
Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose
Z-0558-2024 · Root cause: Device Design · Recall details · FDA record ↗
- Jun 12, 2023Class IIOpen, Classified
The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.
Z-2283-2023 · Root cause: Component design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Activation Failure103
- Radiation Output Failure87
- Positioning Failure30
- No Display/Image21
- Computer Software Problem1
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Erratic or Intermittent Display1
Patient problems
- No Clinical Signs, Symptoms or Conditions245
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 246 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 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 50930222 ↗MalfunctionFeb 26, 2026Activation Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S HOST COMPUTER WAS UNABLE TO BOOT, PREVENTING A 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 24464296 ↗MalfunctionJan 27, 2026Activation Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT 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 24191598 ↗MalfunctionJan 5, 2026Positioning Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE A REMOTE ALERT INDICATING THE "FLEXMOVE XY Y MOTOR CURRENT MARGIN EXCEEDED", PREVENTING GEOMETRY MOVEMENTS. 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 23960393 ↗MalfunctionDec 8, 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 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 23744407 ↗MalfunctionNov 25, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED TO PHILIPS THAT GEOPC FAILURE CAUSED GEOMETRY MOVEMENTS TO BE UNAVAILABLE ON A ALLURA XPER FD20 OR TABLE. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23642905 ↗MalfunctionNov 20, 2025Activation Failure; Activation Failure
IT WAS REPORTED TO PHILIPS THAT THE EQUIPMENT SUDDENLY TURNED OFF DUE TO AN ELECTRICAL BOARD ISSUE ON AN ALLURA XPER FD20 OR TABLE. THE CLINICAL USE OF THE SYSTEM WAS UNKNOWN. THERE WAS NO REPORTED PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23604252 ↗MalfunctionNov 20, 2025Activation Failure; Activation Failure
IT WAS REPORTED TO PHILIPS THAT THE DEVICE WAS UNABLE TO POWER ON, AND THIS WAS REPORTED AS AN ACTIVATION PROBLEM ON AN ALLURA XPER FD20 OR TABLE. THE CLINICAL USE OF THE SYSTEM WAS OUTSIDE OF USE. THERE WAS NO REPORTED PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23604122 ↗MalfunctionNov 20, 2025Activation Failure; Activation Failure
IT WAS REPORTED TO PHILIPS THAT STARTUP FAILURE OCCURRED ON THE FLEXVISION MONITOR CONTROLLER ON AN ALLURA XPER FD20 OR TABLE. THE CLINICAL USE OF THE SYSTEM WAS UNKNOWN. THERE WAS NO REPORTED PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23603941 ↗MalfunctionNov 18, 2025Activation Failure; Activation Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM FAILED TO BOOT DUE TO DEFECTIVE GEO IPC HARDWARE ON AN ALLURA XPER FD20 OR TABLE. THE CLINICAL USE OF THE SYSTEM WAS OUTSIDE OF USE. THERE WAS NO REPORTED PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23583195 ↗MalfunctionNov 10, 2025Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH WAS STICKING, AND A WORKAROUND WAS PROVIDED USING A WIRED FOOTSWITCH ON A ALLURA XPER FD20 OR TABLE. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23510441 ↗MalfunctionNov 7, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED TO PHILIPS THAT THE C-ARM AND OPERATING TABLE WERE BLOCKED DUE TO POWER/CONTROL UNIT FAILURE ON AN ALLURA XPER FD20 OR TABLE. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23498609 ↗MalfunctionNov 6, 2025Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT MULTIPLE HARDWARE ISSUES INCLUDING PEDAL, DISK SPACE, AND BUTTON FAILURE ON A ALLURA XPER FD20 OR TABLE. THE CLINICAL USE OF THE SYSTEM WAS UNKNOWN. THERE WAS NO REPORTED PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23485040 ↗MalfunctionNov 6, 2025No Display/Image; No Display/Image
IT WAS REPORTED TO PHILIPS THAT THE RIGHT-HAND MONITOR BOOM HAD NO IMAGE, WITH THE GREEN LED LIT, ON AN ALLURA XPER FD20 OR TABLE. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23484790 ↗MalfunctionNov 3, 2025Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT THERE WAS NO FLUOROSCOPY AFTER SYSTEM START DUE TO OVERCURRENT IN THE GENERATOR CONVERTER ON AN ALLURA XPER FD20 OR TABLE. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23448720 ↗MalfunctionOct 31, 2025Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT FLUOROSCOPY FAILED DUE TO X-RAY GENERATOR ERRORS ON A ALLURA XPER FD20 OR TABLE. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23441048 ↗MalfunctionOct 31, 2025Activation Failure; Activation Failure
IT WAS REPORTED TO PHILIPS THAT THE LARGE DISPLAY MONITOR FAILED TO BOOT DUE TO A VIDEO SIGNAL ISSUE ON AN ALLURA XPER FD20 OR TABLE. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438600 ↗MalfunctionOct 31, 2025Activation Failure; Activation Failure
IT WAS REPORTED TO PHILIPS THAT PERIODIC ISSUES WITH IP-PC COMPUTER CAUSING SYSTEM MALFUNCTION ON A ALLURA XPER FD20 OR TABLE. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435151 ↗MalfunctionOct 28, 2025Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS DOWN AND FLUOROSCOPY FAILED WITH DISTORTED IMAGE ON A ALLURA XPER FD20 OR TABLE. THE CLINICAL USE OF THE SYSTEM WAS UNKNOWN. THERE WAS NO REPORTED PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23403802 ↗MalfunctionOct 27, 2025Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT A CHARGING SOCKET PIN WAS BROKEN, AFFECTING THE WIFI FOOT SWITCH ON AN ALLURA XPER FD20 OR TABLE. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.
Patient problems: Insufficient Information
MAUDE report 23389548 ↗MalfunctionOct 22, 2025Activation Failure; Activation Failure
IT WAS REPORTED TO PHILIPS THAT HOST PC BOOT FAILURE; SYSTEM OUTSIDE CLINICAL USE ON A ALLURA XPER FD20 OR TABLE. THE CLINICAL USE OF THE SYSTEM WAS OUTSIDE OF USE. THERE WAS NO REPORTED PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23355995 ↗MalfunctionOct 21, 2025Activation Failure; Activation Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT INTO WINDOWS AND THE APPLICATION. THE DEVICE WAS NOT 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 23351798 ↗MalfunctionOct 21, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED TO PHILIPS THAT A TUBE ANODE ERROR CAUSED POOR IMAGE QUALITY, WHICH WAS RESOLVED BY A RESTART ON AN ALLURA XPER FD20 OR TABLE. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23345509 ↗MalfunctionOct 17, 2025Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT FLUORO WAS NOT POSSIBLE DUE TO X-RAY GENERATOR CONNECTION FAILURE ON AN ALLURA XPER FD20 OR TABLE. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23324933 ↗MalfunctionOct 16, 2025Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM FAILED TO EXPOSE DUE TO ONBOARD POWER SUPPLY ISSUE ON A ALLURA XPER FD20 OR TABLE. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23310290 ↗
Other Interventional Fluoroscopic X-Ray System devices
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- Allura Xper FD Allura Xper FD20Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System23 recalls2 deaths3,614 reports
- Azurion Azurion 7 M20Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System32 recalls2 deaths2,308 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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