GE Medical Systems, LLC recalls Mavig Monitor Suspension System, Model GD60, contained in the following Fluoroscopic imaging systems: Advantx LCV+, Adv…

Recall date

December 18, 2015

Source

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

Recall number

Z-0763-2016

FDA classification

Class II

Brand / firm

GE Medical Systems, LLC

Sold / distributed

Worldwide Distribution-US (nationwide) including Guam and Puerto Rico and the countries of Algeria, Angola, Argentina, Australia, Bahrain, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finla…

Why it was recalled

GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor.

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

What was recalled

Mavig Monitor Suspension System, Model GD60, contained in the following Fluoroscopic imaging systems: Advantx LCV+, Advantx LCN+, Advantx LCLP+, Advantx LCA, INNOVA 2000, INNOVA 4100, INNOVA 3100, INNOVA 3131IQ, INNOVA 2121IQ, INNOVA 2100IQ, INNOVA 3100IQ, and INNOVA 4100IQ