Z-1997-2019Class II

Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2

Name: Z-1997-2019 Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
Creator: Philips Medical Systems Nederlands
Published: 2018-11-30
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2018-11-30 / Terminated / root cause: design

FDA source

Philips Medical Systems Nederlands began a recall of Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2 on 2018-11-30. FDA classified it as Class II and gives the reason as "Philips has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with 21 CFR 1003.2(b)(1). When performing Cine runs, the Azurion's automatic exposure...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1997-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-30
Posted: 2019-07-30
Terminated: 2024-03-27
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Philips has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with 21 CFR 1003.2(b)(1). When performing Cine runs, the Azurion's automatic exposure control software may set technique factors that result in radiation emissions too low to obtain useful diagnostic images.
Root cause tag: design
FDA root cause: Device Design
Action: On November 30, 2018, Philips initiated a software update in the field. Among other performance improvements , this software update included the correction for poor image quality under very specific situations.
Quantity in commerce: 229
Distribution: Nationwide
Product codes and lots: software version R1.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1997-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1997-2019	Class II	Terminated	FDA Mandated	2019-08-07	2019-07-30

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)