Recall Z-2205-2019— Philips North America, LLC

Name: FDA recall Z-2205-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-16

Class II · Terminated

Class II FDA medical device recall by Philips North America, LLC, initiated 2019-07-16, terminated 2020-06-04. It names one FDA 510(k) clearance: K172822. 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.. 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..

Recalling firm: Philips North America, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-07-16
Terminated: 2020-06-04
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K172822 — Azurion series R1.2Philips Medical Systems Nederland B.V.·cleared 2017-11-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.