Allura Xper FD Allura Xper FD10 OR Table (REF 722033)Recalls & reported problems
Philips Medical Systems Nederland B.V. · Monoplane Interventional X-Ray System. A ceiling-mounted monoplane system with a 10-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
5 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 5
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838054233), received between Nov 18, 2025 and Nov 18, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Failure” (1 report).
5 FDA recall records name this device's 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, 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 ↗
- 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-1667-2026 · 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-2625-2025 · 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
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED TO PHILIPS THAT HYBRID OR TABLE MOVEMENT AND IMAGE DISK SPACE ISSUES ON A ALLURA XPER FD10 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 23580183 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page