StentBoost LiveRecalls & reported problems across all models

We found 2 models of StentBoost Live by Philips Medical Systems Nederland B.V. in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Mar 10, 2022 and Oct 15, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (1 report).

2 FDA recall records name at least one of these models by its device identifier, 2 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

StentBoost Live 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. Jan 2, 2024Open, Classified

   Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.

   Z-1152-2024 · Root cause: Process design · Recall details · FDA record ↗

2. Dec 12, 2023Open, Classified

   System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure.

   Z-0835-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported StentBoost Live problems

StentBoost Live models

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

• StentBoost Live StentBoost Live - 2

  Interventional Fluoroscopic X-Ray System
  2 recalls2 reports
• StentBoost Live StentBoost Live - 1

  Interventional Fluoroscopic X-Ray System
  1 report

Recent StentBoost Live adverse event reports

The 3 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE FLEXVISION PC FAILED TO BOOT; BIOS RESTORED TO RESOLVE ON A ALLURA XPER FD10. 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 23299443 ↗
• MalfunctionJun 3, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM FAILED TO EXPOSE. 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 22135799 ↗
• MalfunctionMar 10, 2022Patient Data Problem; Patient Data Problem

  IT HAS BEEN REPORTED TO PHILIPS THAT WHEN THE CUSTOMER WAS USING STENTBOOST LIVE DURING A CORONARY PROCEDURE, THE INFORMATION OF A PREVIOUS PATIENT WAS SHOWN INSTEAD OF THE CURRENT PATIENT. A REBOOT OF THE AZURION SYSTEM RESOLVED THE ISSUE. NO HARM TO THE PATIENT HAS BEEN REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT. THIS COMPLAINT IS REPORTED AS THE ISSUE REPORTED RELATES TO MEDICAL DEVICE CORRECTION 2021-IGT-BST-027.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13720680 ↗

Other Philips Medical Systems Nederland B.V. products

• Allura Xper FD19 models · 15,187 reports · 84 recalls
• 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