FDA recall Z-0229-2024

Product

Azurion IGTS Fixed Systems

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

Key facts

Status

Ongoing

Initiation date

2023-10-04

Report date

2023-11-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0229-2024