Philips Medical Systems Nederland B.V.: Medical Device Recall in 2023 - (Recall #: Z-2403-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Azurion

Product Classification:

Class II

Date Initiated: July 19, 2023

Date Posted: September 13, 2023

Recall Number: Z-2403-2023

Event ID: 92855

Reason for Recall:

A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation

Status: Ongoing

Product Quantity: 5432 systems in total

Code Information:

Azurion series

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

FDA Mandated