XperGuide XperGuide - 1Recalls & reported problems
Philips Medical Systems Nederland B.V. · Software medical device, used with a Philips Interventional X-Ray System. Extension of XperCT. Intended to assist the user during percutaneous interventions by providing live 3D needle image guidance. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838059252), received between Apr 21, 2023 and Apr 21, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Image Orientation Incorrect” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Image Orientation Incorrect1
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.
MalfunctionApr 21, 2023Image Orientation Incorrect; Image Orientation Incorrect
IT WAS REPORTED TO PHILIPS THAT DURING A CBCT SCAN THE ORIENTATION OF THE XPERGUIDE DISPLAY WAS UPSIDE DOWN. THE PROCEDURE WAS ABORTED, HOWEVER NO HARM WAS REPORTED TO PHILIPS. THE USER LATER IDENTIFIED THAT THE TABLE TOP WAS POSITIONED BACKWARDS ON THE TABLE BASE (THE HEAD END AT THE FEET AND THE FEET END AT THE HEAD). PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16784718 ↗
Other Interventional Fluoroscopic X-Ray System devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.