Z-0238-2022Class II

Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)

Name: Z-0238-2022 Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
Creator: Philips Healthcare
Published: 2021-09-24
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2021-09-24 / Open, Classified / root cause: software

FDA source

Philips Healthcare began a recall of Philips Azurion systems with software releases 2.1(L1) and 2.1(L2) on 2021-09-24. FDA classified it as Class II and gives the reason as "3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This product extends the functionality of compatible X-ray equipment with the capability of 3D X-ray imaging. Before starting a...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0238-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-09-24
Posted: 2021-11-24
Recalling firm: Philips North America LLC
Product: Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: 3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This product extends the functionality of compatible X-ray equipment with the capability of 3D X-ray imaging. Before starting a 3D-RA scan, the detector of the Philips Azurion system must be positioned in portrait or landscape orientation with an angle of 0 or +/-90 degrees relative to the 3D scan direction. Philips has discovered that Azurion releases 2.1(L1) and 2.1(L2) allow creation of a 3D-RA scan with a deviating detector orientation of up to 3 degrees from the exact portrait or landscape orientation (i.e., at 0 or +/-90 degrees), relative to the 3D scan direction. 3D-RA scans with a deviating detector orientation of ore than 1.0 degree from the exact portrait or landscape orientation (i.e., at 0 or +/-90 degrees) cannot be reconstructed with the 3D-RA reconstruction software.
Root cause tag: software
FDA root cause: Radiation Control for Health and Safety Act
Action: Philips will inform customers of the issue via an Electronic Product Radiation Correction notification. The letter identified the affected product, problem and actions to be taken. Philips Field Service Engineers will schedule an appointment with customers to install the software update. For questions contact your Philips representative at 1-800-722-9377.
Quantity in commerce: 226 units
Distribution: US Nationwide distribution
Product codes and lots: Azurion 2.1(L1) and 2.1(L2)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0238-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0238-2022	Class II	Ongoing	FDA Mandated	2021-12-01	2021-11-24

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)