GE Healthcare, LLC recalls NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general…

Recall date

March 20, 2019

Source

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

Recall number

Z-1261-2019

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK

Why it was recalled

During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.

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

What was recalled

NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The main components of the Discovery NM 630 system are: NM Gantry with Dual detector heads, patient table, Remote Control Unit and NM operation console.