CLASS II Device recall · Reported 27 Dec 2017 · FDA Enforcement Report
Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12 recalled
Philips Electronics North America is recalling Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7, distributed nationwide in the US. The recall was initiated on 18 Aug 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0255-2018
- FDA event ID
- 78739
- Recalling firm
- Philips Electronics North America, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Aug 2017
- FDA classified
- 18 Dec 2017
- Reported
- 27 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Pacemakers & Defibrillators
Timeline
| 18 Aug 2017 | Recall initiated by company | |
| 18 Dec 2017 | Classified by FDA | +122 days |
| 27 Dec 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA (nationwide) Distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
7220063, 722064, 22065, 722066, 722078, 722079
Where was it sold?
Worldwide Distribution - USA (nationwide) Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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