Medical device recalls Moderate risk

GE Healthcare recalls GE Healthcare Precision RXi 23A/32A Analog System

Recall date
June 12, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2121-2015
FDA classification
Class II
Brand / firm
GE Healthcare
Sold / distributed
Worldwide Distribution - US Nationwide Distribution including GU and DC., and to the countries of : Australia, Bulgaria, Canada, Chile, Dominican Republic, Germany, Ireland, Italy, Kuwait, Lebanon, Portugal, Romania, Russia, Saudi Arabia, Slovakia, Spain, Taiwan,Turkey, United Kingdom, Venezuela an…

Why it was recalled

A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affects the single and dual LCD monitor suspensions used on Precision 500D Classical R & F system, Precision RXi 23A/32A Analog System, Precision RXi Digital system and Precision MPi fluoroscopic imaging systems.

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

What was recalled

GE Healthcare Precision RXi 23A/32A Analog System

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