medical Class II Updated 2023-11-15

Philips North America recalls Azurion IGTS Fixed Systems

Recalled Product

Azurion IGTS Fixed Systems


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Azurion 7 M12 465 Azurion 7 M20 702 Azurion 7 M20 942 Azurion 7 M20 948 Azurion 7 M20 503
View official government recall

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