Philips North America Azurion IGTS Fixed Systems Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Azurion IGTS Fixed Systems
Brand
Philips North America
Lot Codes / Batch Numbers
Azurion 7 M12 465 Azurion 7 M20 702 Azurion 7 M20 942 Azurion 7 M20 948 Azurion 7 M20 503
Products Sold
Azurion 7 M12 465 Azurion 7 M20 702 Azurion 7 M20 942 Azurion 7 M20 948 Azurion 7 M20 503
Philips North America is recalling Azurion IGTS Fixed Systems due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
The following details were not provided by the FDA: corrective action details.
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026