Philips North America: Medical Device Recall in 2023 - (Recall #: Z-0229-2024)

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 IGTS Fixed Systems

Product Classification:

Class II

Date Initiated: October 4, 2023

Date Posted: November 15, 2023

Recall Number: Z-0229-2024

Event ID: 93342

Reason for Recall:

Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.

Status: Ongoing

Product Quantity:

Code Information:

Azurion 7 M12 465 Azurion 7 M20 702 Azurion 7 M20 942 Azurion 7 M20 948 Azurion 7 M20 503

Distribution Pattern:

United States Territories of Puerto Rico, Guam, and Virgin Islands

Voluntary or Mandated:

Voluntary: Firm initiated