Z-0255-2018Class II

Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 The Allura Xper...

Name: Z-0255-2018 Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 The Allura Xper...
Creator: Philips Electronics North America Corporation
Published: 2017-08-18
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2017-08-18 / Terminated / root cause: software

FDA source

Philips Electronics North America Corporation began a recall of Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 The Allura Xper series is intended for use on human patients to... on 2017-08-18. FDA classified it as Class II and gives the reason as "When using the downscale option with the Allura R9 system or Azurion R1.1 system, the measurements performed using the QA Basic Measurement tool will not be correctly exported to the external DICOM destination". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0255-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-18
Posted: 2017-12-18
Terminated: 2019-09-26
Recalling firm: Philips North America LLC
Product: Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures ( such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP) Non-vascular interventions such as drainages, biopsies and vertebroplastics procedures The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: When using the downscale option with the Allura R9 system or Azurion R1.1 system, the measurements performed using the QA Basic Measurement tool will not be correctly exported to the external DICOM destination.
Root cause tag: software
FDA root cause: Software design
Action: Image Guided Therapy Systems ( IGT) sent an Urgent - Field Safety Notice Medical Device Correction letter dated August 11. 2017. The Downscale option should be disabled in all Export protocols until Philips corrects this issue. To accomplish this, you may refer to Chapter 13.8 (Configuring Export Protocols) of the system instructions for use that describes how to perform this action. You may also contact your Philips local representative for assistance in performing this action. All archived images exported using the downscale option would be affected by this issue, therefore such measurements from archived images should not be relied on. Additional precaution could be taken by re-performing measurements during the actual interventional procedure. The problem will be resolved by a software update, which is expected to be available by the end of 2017. In the interim, a similar notice will be provided along with newly manufactured devices shipped for use. For further questions, please call (800) 722-9377.
Quantity in commerce: 157
Distribution: Worldwide Distribution - USA (nationwide) Distribution.
Product codes and lots: 7220063, 722064, 22065, 722066, 722078, 722079

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0255-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0255-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-27	2017-12-18

Product code OWB

K162148Class IIAllura Xper R9Philips Medical Systems Nethrlands BV / cleared 2016-11-23

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)