Z-0886-2022Class II

Azurion systems with software release R1.x

Name: Z-0886-2022 Azurion systems with software release R1.x
Creator: Philips Medical Systems Nederland B.v.
Published: 2021-05-26
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2021-05-26 / Open, Classified / root cause: software

FDA source

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of Azurion systems with software release R1.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 Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0886-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-05-26
Posted: 2022-05-03
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Azurion systems with software release R1.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: Software design
Action: Philips notified customers of the issue via Electronic Product Radiation Defect notification letter dated March 4, 2022. The letter identified the affected product, problem and actions to be taken. Customers were informed that they will be contacted by a Philips Field Service Engineers to schedule the software update at no cost. For questions contact your local Philips representative: 1-800-722-9377.
Quantity in commerce: 722 systems
Distribution: US Nationwide and Worldwide Distribution
Product codes and lots: software release R1.x

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0886-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0886-2022	Class II	Ongoing	FDA Mandated	2022-05-11	2022-05-03

Product code OWB

K172822Class IIAzurion series R1.2Philips Medical Systems Nederland B.V. / cleared 2017-11-22

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)