Allura Xper FD Allura Xper FD20/20 OR TableRecalls & reported problems
Philips Medical Systems Nederland B.V. · Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch flat detector), ceiling-mounted lateral stand ( 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
7 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 7
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00884838054271), received between Sep 26, 2023 and Feb 25, 2026 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Radiation Output Failure” (6 reports).
7 FDA recall records name this device's identifier, 7 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 29, 2026Class IIOpen, Classified
Firmware issue potentially leading to loss of geometry movements.
Z-2928-2026 · Root cause: Software design · Recall details · FDA record ↗
- 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 ↗
- 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-1670-2026 · Root cause: Device Design · 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-2631-2025 · 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-0013-2026 · Root cause: Device Design · Recall details · FDA record ↗
- Jun 30, 2025Class IIOpen, Classified
Potential for temporary loss of imaging (X-ray) functionality due to software issue.
Z-2189-2025 · Root cause: Software design · Recall details · FDA record ↗
Most reported problems
Device problems
- Radiation Output Failure6
- Activation Failure5
- No Display/Image2
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Insufficient Information1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2026Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE AN ALERT INDICATING THE IMAGE DISK WAS FULL, PREVENTING EXPOSURE. 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 24442154 ↗MalfunctionNov 8, 2025No Display/Image; No Display/Image
IT WAS REPORTED TO PHILIPS THAT 3D IMAGE UNCLEAR, UNUSABLE FOR DIAGNOSIS AND TREATMENT ON A ALLURA XPER FD20/20 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 23505353 ↗MalfunctionOct 15, 2025Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT EXPOSURE FAILURE OCCURRED DURING USE DUE TO INSUFFICIENT STORAGE SPACE ON AN ALLURA XPER FD20/20 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 23287615 ↗MalfunctionSep 10, 2025No Display/Image; No Display/Image
IT WAS REPORTED TO PHILIPS THAT REAL-TIME MONITOR DISPLAY FAILURE OCCURRED DURING USE ON A ALLURA XPER FD20/20 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 23015593 ↗MalfunctionJun 9, 2025Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT FOOTSWITCH DOES NOT WORK SOMETIMES. THIS IS CONNECTED TO LOSS OF IMAGE RELATED TO A ALLURA XPER FD20/20 OR TABLE. THERE WAS NO REPORTED PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22165546 ↗MalfunctionApr 22, 2025Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT FLUO STORAGE NOT POSSIBLE. THIS IS CONNECTED TO LOSS OF IMAGE RELATED TO A ALLURA XPER FD20/20 OR TABLE. THERE WAS NO REPORTED PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21881332 ↗MalfunctionFeb 21, 2025Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT X-RAY NOT POSSIBLE INTERMITTENTLY. THIS IS CONNECTED TO LOSS OF IMAGE RELATED TO A ALLURA XPER FD20/20 OR TABLE. THERE WAS NO REPORTED PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21434015 ↗MalfunctionJan 9, 2025Activation Failure; Activation Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS STUCK. 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 21108831 ↗MalfunctionJan 3, 2025Activation Failure; Activation Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT UP. 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 21067463 ↗MalfunctionNov 5, 2024Activation Failure; Activation Failure
IT HAS BEEN REPORTED TO PHILIPS THAT THE FLEXVISION PC HAD A BOOT ERROR, WHICH COULD PREVENT THE WHOLE SYSTEM FROM BOOTING. 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 20608549 ↗MalfunctionJun 18, 2024Activation Failure; Activation Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM DID NOT BOOT UP. 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 INTO THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19563655 ↗MalfunctionDec 1, 2023Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S WIRED FOOTSWITCH WOULD NOT ALLOW EXPOSURES TO BE PERFORMED. THE SYSTEM WAS IN CLINICAL USE. 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 18244894 ↗MalfunctionSep 26, 2023Activation Failure; Activation Failure
IT WAS REPORTED TO PHILIPS THAT THE ALLURA DEVICE WOULD NOT BOOT UP. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17822517 ↗
Other Interventional Fluoroscopic X-Ray System devices
- Allura Xper FD Allura Xper FD20Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System25 recalls2 deaths3,984 reports
- 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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