Recall Z-0226-2024— Philips North America

Name: FDA recall Z-0226-2024
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 3 FDA 510(k) clearances: K212813, K183101, K183040. Product: Zenition 50 & 70 Mobile Surgery C-arm. 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

3 on FDA's record

K212813 — Zenition 70Philips Medical Systems Nederland B.V.·cleared 2021-10-01
K183101 — Zenition 50Philips Medical Systems Nederland B.V.·cleared 2018-12-31
K183040 — Zenition 70Philips Medical Systems Nederland B.V.·cleared 2018-12-06

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

Zenition 50 & 70 Mobile Surgery C-arm

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.