FDA Recall
Open, Classified
Azurion IGTS Fixed Systems
Recall: Z-0229-2024
·
Initiated October 4, 2023
Recall
- Recall Number
- Z-0229-2024
- Event Number
- 93342
- Firm
- Philips North America
- FEI Number
- 3006648320
- Product Code
- OWB
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- October 4, 2023
- Posted
- September 30, 2024
- Address
- 222 Jacobs St, Cambridge, MA, 02141-2296
Description
Azurion IGTS Fixed Systems
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.
Distribution
United States Territories of Puerto Rico, Guam, and Virgin Islands