Unrated Medical device recall · FDA · Published October 4, 2023

Philips Allura Xper IGTS Fixed Systems Recall: Missing Tube-spacer in Puerto Rico Models

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0228-2024Medical device Philips ›

Recall notice

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.

Take action

Contact the company

Recalling firmPhilips North America222 Jacobs St · Cambridge, MA 02141-2296

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/57156-philips-allura-xper-igts-fixed-systems-recall-missing-tube-spacer.

Source Summary by GovInfoNow · govinfonow.com/recall/57156-philips-allura-xper-igts-fixed-systems-recall-missing-tube-spacer · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0228-2024

Cite this page

“Philips Allura Xper IGTS Fixed Systems Recall: Missing Tube-spacer in Puerto Rico Models.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57156-philips-allura-xper-igts-fixed-systems-recall-missing-tube-spacer. Based on FDA recall #Z-0228-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0228-2024%22&limit=1).

Philips North America recalled Allura Xper IGTS Fixed Systems delivered to U.S. territories because they lack a warning label and the Source-to-Skin Distance Spacer, according to the FDA on Oct. 4, 2023.

How to tell if you have it

Brand: Philips
Product: Allura Xper IGTS Fixed Systems
Distribution: Puerto Rico, Guam, Virgin Islands

The hazard

The recalled systems were delivered without a required warning label and are missing the Source-to-Skin Distance Spacer (Tube-spacer), according to the FDA.

Context

GovInfoNow's records show Philips North America has issued 30 other recalls since Dec. 24, 2020. Other recent recalls of similar products include Upgrade to MR 7700 (Aug. 28, 2026), Philips PIC iX Essentials Software Freezes (July 31, 2026), and Philips Ingenia Ambition X MRE Scanner Recall (April 14, 2026). Other recent recalls of similar products include Philips Allura Xper Systems: Potential Loss of Imaging Functionality Due to Unauthorized Hard Drives (June 17, 2026), Philips Allura Xper FD10/10 Recall (Dec. 15, 2025), and Philips Allura Xper FD20/20 Recall (Dec. 15, 2025).

How to tell if you have this one

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.

Brand
Philips
Category
Medical device

FDA recall event · 6 products

All 6 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
United States Territories of Puerto Rico, Guam, and Virgin Islands

Recall number	Product, codes & lots	Quantity
Z-0224-2024	BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.; Endura 2.2 1195 Endura 2.2 1202 Endura 2/3 95 Endura 2/3 429 Endura 2/3 443 Endura 2/3 868 Endura 2/3 871 Endura 2/3 998 Endura 2/3 1231 Pulsera 2.2 1623 Pulsera 2.2 1731 Pulsera 2.2 2501 Pulsera 2.2 2507 Pulsera 2.2 641 Pulsera 2.2 884 Pulsera 2.2 882 Pulsera 2.2 1483 Pulsera 2.2 883 Pulsera 2.2 1711 Pulsera 2.3 234 Pulsera 2.3 454 Pulsera 2.3 547 Pulsera 2.3 546 Pulsera 2.3 1044 Pulsera 2.3 1205 Pulsera 2.3 1774 Pulsera 2.3 2709 Pulsera 2.3 3880 Pulsera 2.3 13817 Pulsera 2.3 13818	—
Z-0226-2024	Zenition 50 & 70 Mobile Surgery C-arm; Zenition 50 974 Zenition 50 1244 Zenition 50 1247 Zenition 50 892 Zenition 70 1735 Zenition 70 1824	—
Z-0227-2024	Integris-Allura IGTS Fixed Systems; INTEGRIS Allura 15-12 (mono) 68	—
Z-0228-2024	Allura Xper IGTS Fixed Systems; Allura Xper FD10 285 Allura Xper FD10 1517 Allura Xper FD10 1634 Allura Xper FD10 177 Allura Xper FD10 764 ALLURA Xper FD10 C 249 Allura Xper FD20 2013 Allura Xper FD20 1334 Allura Xper FD20 1473 Allura Xper FD20 2110 Allura Xper FD20 2155 Allura Xper FD20 919 Allura Xper FD20 1581 Allura Xper FD20 2353 Allura Xper FD20 1811 Allura Xper FD20 2087 Allura Xper FD20 53364 Allura Xper FD20/15 172	—
Z-0229-2024	Azurion IGTS Fixed Systems; Azurion 7 M12 465 Azurion 7 M20 702 Azurion 7 M20 942 Azurion 7 M20 948 Azurion 7 M20 503	—
Z-0230-2024	Veradius Unity Mobile Surgery C-arm; Veradius Neo 497 Veradius Neo 607 Veradius Neo 619	—

Based on the official FDA remedy

What to do — step by step

Check for Missing Spacer
Verify if your system has the Source-to-Skin Distance Spacer (Tube-spacer) as part of the recall.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “United States Territories of Puerto Rico, Guam, and Virgin Islands” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 42 days after the firm started it.

Oct 4, 2023Firm started the recall
Nov 9, 2023FDA classified it Class II
Nov 15, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More Philips recalls

Link to this recall

<a href="https://govinfonow.com/recall/57156-philips-allura-xper-igts-fixed-systems-recall-missing-tube-spacer">Philips Allura Xper IGTS Fixed Systems Recall: Missing Tube-spacer in Puerto Rico Models (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-0228-2024 (October 4, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0228-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.