Philips North America: Medical Device Recall in 2023 - (Recall #: Z-0224-2024)

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:

BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.

Product Classification:

Class II

Date Initiated: October 4, 2023

Date Posted: November 15, 2023

Recall Number: Z-0224-2024

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:

Endura 2.2 1195 Endura 2.2 1202 Endura 2/3 95 Endura 2/3 429 Endura 2/3 443 Endura 2/3 868 Endura 2/3 871 Endura 2/3 998 Endura 2/3 1231 Pulsera 2.2 1623 Pulsera 2.2 1731 Pulsera 2.2 2501 Pulsera 2.2 2507 Pulsera 2.2 641 Pulsera 2.2 884 Pulsera 2.2 882 Pulsera 2.2 1483 Pulsera 2.2 883 Pulsera 2.2 1711 Pulsera 2.3 234 Pulsera 2.3 454 Pulsera 2.3 547 Pulsera 2.3 546 Pulsera 2.3 1044 Pulsera 2.3 1205 Pulsera 2.3 1774 Pulsera 2.3 2709 Pulsera 2.3 3880 Pulsera 2.3 13817 Pulsera 2.3 13818

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated