Recall Z-0229-2024— Philips North America

Name: FDA recall Z-0229-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-04

Class II · Ongoing

Class II FDA medical device recall by Philips North America, initiated 2023-10-04. It names one FDA 510(k) clearance: K200917. Product: Azurion IGTS Fixed Systems. Reason: 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..

Recalling firm: Philips North America
Classification: Class II
Status: Ongoing
Initiated: 2023-10-04
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K200917 — Azurion R2.1Philips Medical Systems Nederland B.V.·cleared 2020-05-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Azurion IGTS Fixed Systems

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.