Philips recalls Azurion IGTS Fixed Systems sold in Puerto Rico due to missing warning labels and Source-to-Skin Distance Spacer. Affected units may not function safely without the spacer.
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.
Philips is recalling Azurion IGTS Fixed Systems sold in Puerto Rico because they were delivered without warning labels and lack the required Source-to-Skin Distance Spacer. This could cause improper use if the spacer is missing.
The missing Source-to-Skin Distance Spacer can lead to improper use of the system. Without the spacer, the system may not function correctly, potentially causing safety issues during medical procedures.
Users of Azurion IGTS Fixed Systems in Puerto Rico who received these systems without warning labels are affected. Medical facilities using the systems are most at risk.
Check for Azurion 7 M12 465, Azurion 7 M20 702, Azurion 7 M20 942, Azurion 7 M20 948, or Azurion 7 M20 503 models sold in Puerto Rico. These units were delivered without warning labels and the required spacer.
Ensure the system has a warning label as required by Philips.
Confirm the Source-to-Skin Distance Spacer is included with the system.
Philips has become aware that Azurion IGTS Fixed Systems delivered to Puerto Rico were missing warning labels and the Source-to-Skin Distance Spacer.
The affected models are Azurion 7 M12 465, Azurion 7 M20 702, Azurion 7 M20 942, Azurion 7 M20 948, and Azurion 7 M20 503.
If your system lacks the warning label or Source-to-Skin Distance Spacer, contact Philips for guidance.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0229-2024 — Philips Philips Hello, I own a Philips that is covered by recall Z-0229-2024 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
