Philips North America, LLC: 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.

Recall number

Z-2205-2019

Recalling firm

Philips North America, LLC

Product

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.

Status

Terminated

Initiated

2019-07-16

Posted

not on file

Terminated

2020-06-04

Reason

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.

Root cause

Software design

Action

Philips issued notification on July 16, 2019 advising users of the problem, health risk and action to take: If the start-up screen shows software version R1 .2, your system has the affected release and FC072200430 should be implemented on your system. If the start-up screen shows software version R1.2.1, your system has the latest system software release and is not affected by this issue. Philips will also be contacting customers with affected systems directly. Until Philips corrects your Philips Azurion system. At least once every 50 days, briefly disconnect the Azurion system from the mains power supply. Be aware that when an Uninterruptible Power Supply (UPS) is installed, the room emergency power off switch should be used to interrupt the mains power supply to the system. Note that this might also shut down other devices or equipment in the room. . Include this Field Safety Notice with the documentation of the system until Philips implements this correction in your system. Questions contact : your local Philips representative

Quantity

834

Distribution

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

Lot, serial or model codes

Software version R1.2

510(k) numbers

["K172822"]

PMA numbers

not on file

Product code

OWB

Firm FEI

1218950

Firm city

Andover

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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