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Philips Medical Systems Nederland B.V.

Philips Medical Systems Nederland B.V.: 18 recalls listed since January 2026 across FDA.

By year

  • 202618

By agency

  • FDA18

By category

  • Medical Device18

All recalls (18)

Philips Azurion

Philips Azurion x-ray system has software issues that may delay therapy and cause procedural complications.

Moderate risk, FDA, , Software defect

Philips Azurion Interventional Fluoroscopic X-Ray Systems

Philips Azurion Rystem has software issues that may delay therapy and cause procedural complications.

Moderate risk, FDA, , Software defect

Philips Allura Xper FD Interventional Fluoroscopic X-Ray Systems

Allura Xper FD has a firmware issue that could lead to loss of geometry movements.

Moderate risk, FDA, , Software defect

Philips Allura and Azurion X-Ray Systems

Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

Moderate risk, FDA, , Device defect

Philips MultiDiagnost Eleva and Allura Xper Systems

Philips MultiDiagnost Eleva and Allura Xper systems have a hand switch button that may not fully release.

Moderate risk, FDA, , Device defect

Philips Azurion 3M12, 3M15, 5M12 and Other Angiography Systems

Philips Azurion systems may show a dark image during Roadmap Pro, not clinically usable.

Moderate risk, FDA, , Device defect

Philips Azurion and Allura Systems

The Azurion system may show decreased performance as it ages, potentially causing loss of imaging functionality.

Moderate risk, FDA, , Device defect

Philips Azurion Systems

Philips Azurion systems may have table movements impacted due to mechanical wear of the Float Tabletop control.

Moderate risk, FDA, , Device defect

Philips Azurion, Allura and Integris-Allura Systems

The Azurion system's deaeration hose may degrade, potentially causing oil leakage that affects cooling performance.

Moderate risk, FDA, , Device defect

Philips Azurion

Philips Azurion has bolts and plastic parts that may loosen or break.

Moderate risk, FDA, , Device defect

Philips AneurysmFlow

Philips AneurysmFlow software may not provide reliable prognostic information about aneurysm occlusion after Flow Diverter Stent treatment.

Moderate risk, FDA, , Device defect

Philips Allura Xper and Azurion Angiography Systems

Philips Allura Xper and Azurion systems may not initiate X-ray imaging or may do so intermittently when using the wired foot switch.

Moderate risk, FDA, , Device defect

Philips Vue Motion V12

Vue Motion V12 may display image frames out of sequence during dynamic cine runs.

Moderate risk, FDA, , Device defect

Philips Azurion Systems

Azurion systems may move unexpectedly when the Reset Geometry button is pressed, even with a table lock active.

Moderate risk, FDA, , Device defect

Philips Azurion System

Issue 1 - System remains in continuous restart mode after the start-up.

Moderate risk, FDA, , Software defect

Philips Azurion Systems

Philips Azurion Systems R3.0 have software issues that may cause loss of X-ray and other problems.

Moderate risk, FDA, , Software defect

Philips Azurion Systems

Philips Azurion Systems have software issues that may cause system restarts and positional errors.

Moderate risk, FDA, , Software defect

Philips Allura Xper FD10, FD20 and Biplane Systems

Philips Allura Xper systems may have a missing drip tray, allowing coolant to contact electrical components and cause short-circuits.

Moderate risk, FDA, , Device defect
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