CLASS II ONGOING Device recall · Reported 15 Nov 2023 · FDA Enforcement Report
Azurion IGTS Fixed Systems recalled by Philips North America
Philips North America is recalling Azurion IGTS Fixed Systems, distributed in Puerto Rico. The recall was initiated on 4 Oct 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0229-2024
- FDA event ID
- 93342
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Oct 2023
- FDA classified
- 9 Nov 2023
- Reported
- 15 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 4 Oct 2023 | Recall initiated by company | |
| 9 Nov 2023 | Classified by FDA | +36 days |
| 15 Nov 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Azurion IGTS Fixed Systems
Where it was distributed
United States Territories of Puerto Rico, Guam, and Virgin Islands
Questions about this recall
Is Azurion IGTS Fixed Systems recalled?
Yes. Philips North America recalled Azurion IGTS Fixed Systems on 4 Oct 2023. The recall is Class II and its status is Ongoing. Recall number Z-0229-2024.
Why was it recalled?
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.
Which lots are affected?
Azurion 7 M12 465 Azurion 7 M20 702 Azurion 7 M20 942 Azurion 7 M20 948 Azurion 7 M20 503
Where was it sold?
United States Territories of Puerto Rico, Guam, and Virgin Islands
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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