Philips North America: Medical Device Recall in 2023 - (Recall #: Z-0228-2024)

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:

Allura Xper IGTS Fixed Systems

Product Classification:

Class II

Date Initiated: October 4, 2023

Date Posted: November 15, 2023

Recall Number: Z-0228-2024

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:

Allura Xper FD10 285 Allura Xper FD10 1517 Allura Xper FD10 1634 Allura Xper FD10 177 Allura Xper FD10 764 ALLURA Xper FD10 C 249 Allura Xper FD20 2013 Allura Xper FD20 1334 Allura Xper FD20 1473 Allura Xper FD20 2110 Allura Xper FD20 2155 Allura Xper FD20 919 Allura Xper FD20 1581 Allura Xper FD20 2353 Allura Xper FD20 1811 Allura Xper FD20 2087 Allura Xper FD20 53364 Allura Xper FD20/15 172

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated