Integris-Allura IGTS Fixed Systems
This recall is currently active, issued September 30, 2024. It was issued by Philips North America.
- Company
- Philips North America
- Recall Initiated
- October 4, 2023
- Posted
- September 30, 2024
- Recall Number
- Z-0227-2024
- Firm Location
- Cambridge, MA
- Official Source
- View on FDA website ↗
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
United States Territories of Puerto Rico, Guam, and Virgin Islands
Lot / Code Info
INTEGRIS Allura 15-12 (mono) 68
Root Cause
Device Design
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