Z-0229-2024Class II

Azurion IGTS Fixed Systems

Name: Z-0229-2024 Azurion IGTS Fixed Systems
Creator: Philips North America
Published: 2023-10-04
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2023-10-04 / Open, Classified / root cause: design

FDA source

Philips North America began a recall of Azurion IGTS Fixed Systems on 2023-10-04. FDA classified it as Class II and gives the reason as "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)...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0229-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-04
Posted: 2024-09-30
Recalling firm: Philips North America LLC
Product: Azurion IGTS Fixed Systems
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
Root cause tag: design
FDA root cause: Device Design
Distribution: United States Territories of Puerto Rico, Guam, and Virgin Islands
Product codes and lots: Azurion 7 M12 465 Azurion 7 M20 702 Azurion 7 M20 942 Azurion 7 M20 948 Azurion 7 M20 503

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0229-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0224-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-09
Z-0226-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-09
Z-0227-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-09
Z-0228-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-09
Z-0229-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-09
Z-0230-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-09

Product code OWB

K200917Class IIAzurion R2.1Philips Medical Systems Nederland B.V. / cleared 2020-05-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)