Philips Integris-All: Missing Tube-spacer in Puerto Rico Models

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Contact the company & request your remedy

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Philips is recalling Integris-Allura IGTS Fixed Systems sold in Puerto Rico because they lack a warning label and have a missing tube-spacer. This could cause the system to malfunction or not operate safely.

Why it’s dangerous

The missing tube-spacer can cause the system to malfunction or not operate safely. Without the warning label, users may not be aware of the issue, increasing the risk of improper use.

Who’s affected

Users in Puerto Rico who purchased Philips Integris-Allura IGTS Fixed Systems with the model numbers INTEGRIS Allura 15-12 (mono) 68 are affected. Those who have the missing tube-spacer or no warning label are at risk.

How to tell if you have this one

Check for the model numbers INTEGRIS Allura 15-12 (mono) 68 sold in Puerto Rico. The affected units lack a warning label and have a missing tube-spacer.

Brand
Philips
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Warning Label
Ensure the unit has the warning label as required by Philips.
Verify Tube-spacer Presence
Confirm the tube-spacer is included with the system.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

Philips has become aware of an issue with the Integris-Allura IGTS Fixed Systems delivered to Puerto Rico without a warning label and with a missing tube-spacer.

What models are affected?

The affected models are INTEGRIS Allura 15-12 (mono) 68 sold in Puerto Rico.

Do I need to stop using this product?

The recall does not specify a stop-use instruction; users should check for the warning label and tube-spacer.

Take action

Contact Philips

We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0227-2024 — Philips Philips

Hello,

I own a Philips that is covered by recall Z-0227-2024 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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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-0227-2024 (October 4, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0227-2024 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.

Philips North America recalls Integris-Allura IGTS Fixed Systems

Recall notice