Allura Xper FDRecalls & reported problems across all models

We found 19 models of Allura Xper FD by Philips Medical Systems Nederland B.V. in the FDA's device registry (GUDID). Together they are named in 15,187 adverse event reports in the FDA's MAUDE database, received between Jun 15, 2017 and Sep 30, 2026 — classified as 13 deaths, 52 injuries, 15,122 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (7,167 reports).

84 FDA recall records name at least one of these models by its device identifier, 82 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

Allura Xper FD 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.

1. Jun 29, 2026Open, Classified

   Firmware issue potentially leading to loss of geometry movements.

   Z-2928-2026 · Root cause: Software design · names 7 of these models · Recall details · FDA record ↗

2. Jun 17, 2026Open, 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 · names 18 of these models · Recall details · FDA record ↗

3. Apr 30, 2026Open, 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 · names 17 of these models · Recall details · FDA record ↗

4. Apr 28, 2026Open, 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 · names 14 of these models · Recall details · FDA record ↗

5. Mar 19, 2026Open, Classified

   Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions.

   Z-1805-2026 · Root cause: Labeling design · names 8 of these models · Recall details · FDA record ↗

6. Mar 3, 2026Open, Classified

   Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

   Z-1672-2026 · Root cause: Device Design · Recall details · FDA record ↗

7. Mar 3, 2026Open, Classified

   Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

   Z-1671-2026 · Root cause: Device Design · Recall details · FDA record ↗

8. Mar 3, 2026Open, 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 ↗

9. Mar 3, 2026Open, Classified

   Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

   Z-1669-2026 · Root cause: Device Design · Recall details · FDA record ↗

10. Mar 3, 2026Open, Classified

    Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

    Z-1668-2026 · Root cause: Device Design · Recall details · FDA record ↗

11. Mar 3, 2026Open, Classified

    Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

    Z-1667-2026 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

12. Mar 3, 2026Open, Classified

    Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

    Z-1666-2026 · Root cause: Device Design · Recall details · FDA record ↗

13. Mar 3, 2026Open, 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 · names 2 of these models · Recall details · FDA record ↗

14. Mar 3, 2026Open, Classified

    Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

    Z-1664-2026 · Root cause: Device Design · Recall details · FDA record ↗

15. Mar 3, 2026Open, Classified

    Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

    Z-1663-2026 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

16. Mar 3, 2026Open, Classified

    Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

    Z-1662-2026 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

17. Mar 3, 2026Open, Classified

    Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

    Z-1661-2026 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

18. Dec 15, 2025Open, 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-1077-2026 · Root cause: Other · Recall details · FDA record ↗

19. Dec 15, 2025Open, 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-1076-2026 · Root cause: Other · Recall details · FDA record ↗

20. Dec 15, 2025Open, 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-1075-2026 · Root cause: Other · Recall details · FDA record ↗

21. Dec 15, 2025Open, 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-1074-2026 · Root cause: Other · Recall details · FDA record ↗

22. Dec 15, 2025Open, 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-1073-2026 · Root cause: Other · Recall details · FDA record ↗

23. Dec 15, 2025Open, 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 ↗

24. Dec 15, 2025Open, 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-1071-2026 · Root cause: Other · Recall details · FDA record ↗

25. Dec 15, 2025Open, 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-1070-2026 · Root cause: Other · Recall details · FDA record ↗

26. Dec 15, 2025Open, 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-1069-2026 · Root cause: Other · Recall details · FDA record ↗

27. Dec 15, 2025Open, 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-1068-2026 · Root cause: Other · Recall details · FDA record ↗

28. Sep 3, 2025Open, 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 ↗

29. Sep 3, 2025Open, 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-0012-2026 · Root cause: Device Design · Recall details · FDA record ↗

30. Sep 3, 2025Open, 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-0011-2026 · Root cause: Device Design · Recall details · FDA record ↗

…and 54 older recalls, listed on each model's page.

Most reported Allura Xper FD problems

Allura Xper FD models

19 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Allura Xper FD Allura Xper FD20

  Interventional Fluoroscopic X-Ray System
  25 recalls2 deaths3,984 reports
• Allura Xper FD Allura Xper FD20

  Interventional Fluoroscopic X-Ray System
  23 recalls2 deaths3,614 reports
• Allura Xper FD Allura Xper FD10

  Interventional Fluoroscopic X-Ray System
  23 recalls2 deaths2,015 reports
• Allura Xper FD Allura Xper FD10

  Interventional Fluoroscopic X-Ray System
  20 recalls2 deaths1,837 reports
• Allura Xper FD Allura Xper FD20/15

  Interventional Fluoroscopic X-Ray System
  20 recalls2 deaths776 reports
• Allura Xper FD Allura Xper FD20 Biplane

  Interventional Fluoroscopic X-Ray System
  16 recalls3 deaths792 reports
• Allura Xper FD Allura Xper FD10/10

  Interventional Fluoroscopic X-Ray System
  19 recalls603 reports
• Allura Xper FD Allura Xper FD20 OR Table

  Interventional Fluoroscopic X-Ray System
  18 recalls411 reports
• Allura Xper FD Allura Xper FD20/20

  Interventional Fluoroscopic X-Ray System
  18 recalls250 reports
• Allura Xper FD Allura Xper FD20/10

  Interventional Fluoroscopic X-Ray System
  19 recalls172 reports
• Allura Xper FD Allura Xper FD20 OR Table

  Interventional Fluoroscopic X-Ray System
  15 recalls246 reports
• Allura Xper FD Allura Xper FD10/10

  Interventional Fluoroscopic X-Ray System
  10 recalls449 reports
• Allura Xper FD Allura Xper FD20/15 OR Table

  Interventional Fluoroscopic X-Ray System
  12 recalls16 reports
• Allura Xper FD Allura Xper FD20/20 OR Table

  Interventional Fluoroscopic X-Ray System
  7 recalls13 reports
• Allura Xper FD Allura Xper FD20 Biplane OR Table

  Interventional Fluoroscopic X-Ray System
  7 recalls2 reports
• Allura Xper FD Allura Xper FD10 OR Table

  Interventional Fluoroscopic X-Ray System
  5 recalls6 reports
• Allura Xper FD Allura Xper FD10 OR Table

  Interventional Fluoroscopic X-Ray System
  5 recalls1 report
• Allura Xper FD Allura Xper R9 7 M12

  Interventional Fluoroscopic X-Ray System
  1 recall0 reports
• Allura Xper FD Allura Xper R9 7 M20

  System, X-Ray, Fluoroscopic, Image-Intensified
  1 recall0 reports

Recent Allura Xper FD adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Radiation Output Failure

  It was reported to Philips that the fluoroscopy foot pedal was not functioning. The device was in clinical use at the time of the event. The patient¿s procedure was cancelled and rescheduled due to the loss of fluoroscopy functionality.Philips has started an investigation of this complaint.

  Patient problems: Needle Stick/Puncture

  MAUDE report 50943850 ↗
• MalfunctionSep 30, 2026Radiation Output Failure

  It was reported to Philips that the system was unable to perform exposure.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 50942746 ↗
• MalfunctionSep 30, 2026Activation Failure

  It was reported to Philips that the system was experiencing booting issues.The system was not in clinical use during the event. No harm was reported to the user or the patient during the event.Philips has started an investigation of this complaint.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942592 ↗
• 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 ↗
• MalfunctionSep 29, 2026Radiation Output Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929613 ↗
• MalfunctionSep 29, 2026Positioning Failure

  It was reported to Philips that the system geometry movements were not available.The system was in clinical use at the time of the event. No harm to the patient or user was reported to Philips.Philips has started an investigation of this complaint.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929518 ↗
• MalfunctionSep 29, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929402 ↗
• MalfunctionSep 29, 2026Radiation Output Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929182 ↗
• MalfunctionSep 29, 2026Radiation Output Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929181 ↗
• MalfunctionSep 29, 2026No Display/Image

  It was reported to Philips that the Flexvision monitor was unable to display images. 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 50929180 ↗
• MalfunctionSep 29, 2026Unexpected Deactivation

  It was reported to Philips that there was smoke inside the cabinet room.The system was not in clinical use during the event. No harm was reported to Philips or the patient during the event.Philips has started an investigation of this complaint.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927823 ↗
• MalfunctionSep 28, 2026Positioning Failure

  It was reported to Philips that the C-arm of the system moves in the opposite direction.The system was in clinical use at the time of the event. No harm to the patient or user was reported to Philips.Philips has started an investigation of this complaint.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913559 ↗
• MalfunctionSep 28, 2026Radiation Output Failure

  It was reported to Philips that the system was unable to emit X-ray.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 50911262 ↗
• MalfunctionSep 25, 2026Insufficient Device Problem Information

  It was reported to Philips that the Wall connection box was defective.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 50896674 ↗
• MalfunctionSep 25, 2026Activation Failure

  It was reported to Philips that the Host computer 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 50894804 ↗

Other Philips Medical Systems Nederland B.V. products

• 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
• Zenition2 models · 101 reports · 5 recalls