CLASS II Device recall · Reported 14 Aug 2019 · FDA Enforcement Report

Philips Azurion systems recalled by Philips North America

Philips North America is recalling Philips Azurion systems, distributed nationwide in the US. The recall was initiated on 16 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware version R1.2

Quantity recalled834

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-2205-2019
FDA event ID: 83477
Recalling firm: Philips North America, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 16 Jul 2019
FDA classified: 6 Aug 2019
Reported: 14 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

16 Jul 2019	Recall initiated by company
6 Aug 2019	Classified by FDA	+21 days
14 Aug 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to the mains power supply for more than 50 days, may result in a delay of treatment.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20 Models: 722063, 722064, 722067, 722068, 722078, 722079. Product Usage: The Azurion series (within the limits of the used Operating 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. Additionally: . The Azurion series can be used in a hybrid Operating Room. The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.

Where it was distributed

US Nationwide Distribution Foreign: Canada Argentina AUSTRALIA Austria Azerbaijan Bahrain Bangladesh Belgium Bosnia and Herzegovina Brazil Bulgaria Chile Colombia CROATIA Denmark ECUADOR Egypt Finland France Germany Greece Hong Kong India Indonesia Ireland Israel Italie Italy Japan Jordan Kazakhstan Korea, Republic of Latvia Lebanon Libya Malaysia Maldives Mexico Mongolia Myanmar Netherlands New Zealand Norway Oman Pakistan Philippines Polamnd Poland Portugal Republic of Korea Romania Russian Federation Saudi Arabia Serbia Singapore SLOVENIA South Africa Spain Sri Lanka Sweden Switzerland Thailand Tunisia Turkey UNITED ARAB EMI United Arab Emirates United Kingdom Uzbekistan Viet Nam

Nationwide

Questions about this recall

Is Philips Azurion systems recalled?

Yes. Philips North America recalled Philips Azurion systems on 16 Jul 2019. The recall is Class II and its status is Terminated. Recall number Z-2205-2019.

Why was it recalled?

The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to the mains power supply for more than 50 days, may result in a delay of treatment.

Which lots are affected?

Software version R1.2

Where was it sold?

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 21 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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