Philips Azurion systems with software version R1.2 -Interventional Fluor ...



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.
Components:
Units Affected:    834
Recall Date:    Jul 16, 2019
Mfg:
Philips North America, LLC
Mfg Country:
United States
Recall ID:    83477
Product ID:    175362
Enforcement Date:    Aug 14, 2019
Termination Date:    Jun 4, 2020
Last Published:    Jun 4, 2020

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Emert Number:    Z-2205-2019
Emert Status:    Terminated