Philips recalls Allura Xper IGTS Fixed Systems sold in Puerto Rico due to missing Source-to-Skin Distance Spacer (Tube-spacer). Affected models lack warning labels and require immediate attention.
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 Allura Xper IGTS Fixed Systems sold in Puerto Rico because they were delivered without warning labels and missing the Source-to-Skin Distance Spacer (Tube-spacer). This could lead to improper use if the spacer is needed for safety.
The missing Source-to-Skin Distance Spacer (Tube-spacer) could lead to improper use of the imaging system. Without this spacer, the system might not function correctly, potentially causing safety issues during medical procedures.
Owners of Allura Xper IGTS Fixed Systems delivered to Puerto Rico without warning labels are affected. Those using these systems for medical imaging may be at risk if the missing spacer causes improper operation.
Check for models listed in the recall: Allura Xper FD10 285, FD10 1517, FD10 1634, FD10 177, FD10 764, FD20 2013, FD20 1334, FD20 1473, FD20 2110, FD20 2155, FD20 919, FD20 1581, FD20 2353, FD20 1811, FD20 2087, FD20 53364, and FD20/15 172. These were delivered to Puerto Rico without warning labels.
Verify if your system has the Source-to-Skin Distance Spacer (Tube-spacer) as part of the recall.
Philips has become aware that Allura Xper IGTS Fixed Systems delivered to Puerto Rico were sold without warning labels and missing the Source-to-Skin Distance Spacer (Tube-spacer).
Affected models include Allura Xper FD10 285, FD10 1517, FD10 1634, FD10 177, FD10 764, FD20 2013, FD20 1334, FD20 1473, FD20 2110, FD20 2155, FD20 919, FD20 1581, FD20 2353, FD20 1811, FD20 2087, FD20 53364, and FD20/15 172.
The recall does not specify a stop-use instruction; the remedy is null, so users should check for the missing spacer.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0228-2024 — Philips Philips Hello, I own a Philips that is covered by recall Z-0228-2024 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.
