Z-0734-2022Class II

Azurion systems with software release R2.0.x

Name: Z-0734-2022 Azurion systems with software release R2.0.x
Creator: Philips Healthcare
Published: 2021-05-26
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2021-05-26 / Completed / root cause: software

FDA source

Philips Healthcare began a recall of Azurion systems with software release R2.0.x on 2021-05-26. FDA classified it as Class II and gives the reason as "In the Azurion system, the user can add a new study to a patient by selecting the option "Add Study". The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as software.

Recall record

Recall number: Z-0734-2022
Classification: Class II
Status: Completed
Initiated: 2021-05-26
Posted: 2022-03-23
Recalling firm: Philips North America LLC
Product: Azurion systems with software release R2.0.x
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: In the Azurion system, the user can add a new study to a patient by selecting the option "Add Study". The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure , the Patient Type changes inadvertently to a Patient Type different than the one selected as shown in the Table below. Patient type is one of the factors involved in the dose control process. The incorrect patient type changes the technique factors to be used by the system without notification to the user.
Root cause tag: software
FDA root cause: Radiation Control for Health and Safety Act
Action: Philips notified customers of the issue via an Electronic Product Radiation Defect notification letter dated February 8, 2022. Philips Field Service Engineers will schedule an appointment with customers to install the software update. Philips will correct the affected systems at no cost to customers with a software upgrade. For information, contact your local Philips representative: 1-800-722-9377.
Quantity in commerce: 69 systems
Distribution: US Nationwide Distribution
Product codes and lots: Model(s) Azurion R2.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0734-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0734-2022	Class II	Completed	FDA Mandated	2022-03-30	2022-03-23

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)