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Recall Observatory FDA recall evidence

Device product

Integris-Allura IGTS Fixed Systems

Z-0227-2024

October 04, 2023

Class II

Product summary

Firm
Philips North America
Event
Event 93342
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-0227-2024

Official wording

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.

Code information: INTEGRIS Allura 15-12 (mono) 68

Distribution pattern: United States Territories of Puerto Rico, Guam, and Virgin Islands

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.