—#175362

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.

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K172822
Affected lot / code info: Software version R1.2

Why it was 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.

Root cause (FDA determination)

Software design

Action the firm took

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

Recalling firm

Firm: Philips North America, LLC
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2019-07-16
Terminated: 2020-06-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #175362. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.