Philips North America, LLC recalls Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and minimall…

Recall date

March 5, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1801-2020

FDA classification

Class II

Brand / firm

Philips North America, LLC

Sold / distributed

Worldwide distribution: US (nationwide) including the following states: Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio…

Why it was recalled

No torque was specified for the four screws that connect the gearbox and the mounting flange within the C-arm roll motor which could result in the screws becoming loose..

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures.