Home / Recalls / Philips North America / Z-0226-2024

Z-0226-2024 Class II Ongoing

Recalled by Philips North America — Cambridge, MA

Recall Details

Product Type
Devices
Report Date
November 15, 2023
Initiation Date
October 4, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

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.

Distribution Pattern

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

Code Information

Zenition 50 974 Zenition 50 1244 Zenition 50 1247 Zenition 50 892 Zenition 70 1735 Zenition 70 1824

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