FDA Enforcement
Class II
Ongoing
Azurion IGTS Fixed Systems
Recall: Z-0229-2024
·
Reported November 15, 2023
Enforcement
- Recall Number
- Z-0229-2024
- Event ID
- 93342
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Philips North America
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 15, 2023
- Initiation Date
- October 4, 2023
- Classification Date
- November 9, 2023
- Address
- 222 Jacobs St, Cambridge, MA, 02141-2296, United States
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.
Code Info
Azurion 7 M12 465 Azurion 7 M20 702 Azurion 7 M20 942 Azurion 7 M20 948 Azurion 7 M20 503
Distribution
United States Territories of Puerto Rico, Guam, and Virgin Islands