FDA-Device2023-11-15Class II
Integris-Allura IGTS Fixed Systems
Philips North America
Hazard
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.
Sold states
United States Territories of Puerto Rico, Guam, and Virgin Islands
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
Integris-Allura IGTS Fixed Systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0227-2024Don't want to check this manually?
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